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- 2026-03-11 16:33:51
- Company
- Osteonoic secures rights to J&J’s bone graft material
- by Lee, Seok-Jun Feb 19, 2025 05:56am
- Osteonic, a company specializing in implants for orthopedic surgery, announced on the 17th that it has secured the domestic rights to DBX Putty, a bone graft material, from Johnson & Johnson Medtech Korea. DBX Putty was developed by MTF Biologics Inc., a US bone graft manufacturer. Johnson & Johnson MedTech holds the global rights to the product, and Osteonic has secured the domestic rights through this agreement. DBX Putty is a DBM (Demineralized Bone Material) based bone graft. It is made by removing minerals from human bones and is used to reconstruct bone formation by implanting it into damaged bone parts or during spinal surgery. In particular, it has both osteoconductive and osteogenic functions because it is a mixture of mineral-removed cortical bone powder and highly biocompatible hyaluronic acid. This allows it to maintain the proper viscosity depending on the surgical situation and is highly regarded for its excellent osteogenesis and formability. Its quality has also been verified as a product that has been used in leading university hospitals and hospitals specializing in spinal joints in Korea for nearly 20 years. According to Fortune Business Insights, a global market research firm, the global market size of bone substitutes and bone grafts is estimated to be USD 5.7 billion (about KRW 7 trillion) in 2029, and about KRW 100 billion in Korea. Osteonic continues to grow by leveraging its full line-up of orthopedic implants that make up the human body, including Sports Medicine (soft tissue reconstruction), CMF (craniomaxillofacial), Trauma (upper and lower limb fractures), and Spine. Dong-won Lee, CEO of Osteonic, said, “Along with our existing business of treating fractures and spinal fixation implants, we plan to expand our business into the field of bone grafting materials through this licensing agreement and provide a wide range of musculoskeletal medical solutions.”
- Company
- Next reimb effort for 'Padcev combination therapy'
- by Moon, sung-ho Feb 19, 2025 05:56am
- 'Padcev Combination therapy' has been reported to have changed the urothelial cancer treatment paradigm after 30 years. After its launch in clinical practices in South Korea in the second half of last year, the government has initiated discussion for reimbursement of the therapy. Product photo of Keytruda and Padcev.According to the pharmaceutical industry on February 17, the Health Insurance Review and Assessment Service (HIRA) recently held the first Cancer Disease Review Committee (CDRC) for this year and discussed setting the reimbursement standards for the combination therapy containing Padcev (enfortumab, Astellas Pharma Korea) and Keytruda (pembrolizumab, MSD Korea). Padev was launched and became available for prescription in South Korea last year. It is an ADC anticancer agent for treating patients with metastatic urothelial carcinoma who failed previous treatments. In July 2024, indications were expanded as a first-line treatment in combination with Keytruda. Thus, Padcev is now an ADC anticancer agent approved for use in first-line to third-line treatments for metastatic urothelial carcinoma. Domestic approval was based on the EV-302 clinical study presented during the 2023 Congress of the European Society for Medical Oncology (ESMO Congress 2023). EV-302 is a randomized Phase 3 clinical study evaluating the effectiveness of Padcev+Keytruda combination therapy compared to platinum-based chemotherapy in 886 patients in 25 countries. Based on the study, at the median follow-up of 17.2 months, patients treated with Padcev combination therapy had a median overall survival (OS) of 31.5 months, extending the OS by approximately twofold compared to the platinum-based chemotherapy group and reducing death risk by 53%. The median progression-free survival (mPFS) of the combination therapy group was 12.5 months, and the mPFS of the platinum-based chemotherapy group was 6.3 months. The Padcev combination therapy extended the mPFS by approximately twofold. Based on this result, Astellas Pharma applied for reimbursement to the HIRA at the end of last year, and it has been considered for the first CDRC review for this year. However, the drug failed to pass the CDRC review after receiving the decision of 'reimbursement standards non-established.' Interestingly, Astellas Pharma had applied for reimbursement alone and its application was considered for the CDRC review. In the past, the review would have required applying for reimbursement with the Keytruda owner MSD. The policy has changed based on the global pharmaceutical companies' headquarters policy and the domestic‧foreign Fair Trade Act, and discussion with another pharmaceutical company can be considered 'price fixing.' As for Keytruda, which is used along with Padcev, MSD has not applied for reimbursement. It has been reported that MSD has applied for 17 indications, so the company may have been reluctant to file an additional one. However, the pharmaceutical industry believes that HIRA's approach toward combination therapies may have changed after the decision on the Padcev combination therapy. At the end of last year, HIRA announced the establishment of a review policy for reimbursement decisions on combination therapies. A pharmaceutical industry employee said who asked for anonymity said, "Last year, the CDRC review established a review policy for deciding on the reimbursement of combination therapies. However, the policy was limited to cases where a new drug is added to a previously reimbursed drug." He added, "The review of Padcev combination therapy indicates that an approach towards new drugs can be changed."
- Company
- Will Tevimbra become the 1st reimbursed immunooncology drug?
- by Eo, Yun-Ho Feb 19, 2025 05:56am
- Will the first immuno-oncology treatment option in the field of esophageal cancer finally be born in Korea? BeiGene Korea's immuno-oncology drug Tevimbra (tiselizumab), which passed the Health Insurance Review and Assessment Service’s Drug Reimbursement Evaluation Committee review last month, has entered into drug price negotiations with the National Health Insurance Service for insurance reimbursement. This comes about half a year after the drug passed the Cancer Disease Deliberation Committee review in August 2024 after a reattempt. Tevimbra is a PD-1 inhibitory immuno-oncology drug that has demonstrated clinical utility in second-line esophageal squamous cell carcinoma and was approved in Korea in November last year. Currently, there are seven immuno-oncology drugs approved and marketed in Korea: ▲Keytruda, ▲ Opdivo, ▲Tecentriq, ▲Imfinzi, ▲Bavencio, ▲Jemperli, and ▲Tevimbra, which have 64 indications. However, only 21 therapies (about 33%) are currently listed for reimbursement. None of these drugs are yet on the reimbursement list for esophageal cancer. Currently, only platinum-based chemotherapy is reimbursed in Korea as both first-line and second-line treatment options for esophageal squamous cell carcinoma. Reimbursement rates for immuno-oncology drugs by indication, including esophageal cancer, are low due to drug prices and national health insurance finances. Since the drugs were reimbursed for some cancers, such as lung cancer, the overall claims of immuno-oncology drugs and their share in health insurance finance expenditures have increased significantly, raising Korea’s financial burden. As of 2023, the total claims for anti-cancer drugs reached KRW 2.4 trillion, while claims for immuno-oncology drugs were KRW 500 billion, accounting for 20% of the total claims for anti-cancer drugs. This is why the industry is welcoming the news of BeiGene's initiation of drug price negotiations for Tevimbra, as the company has announced its intention to supply the drug at a relatively low price. BeiGene’s philosophy of providing “innovative new medicines at affordable prices” and eliminating underserved patients has already been demonstrated through the reimbursement process for its blood cancer drug Brukinsa (zanubrutinib). The company has also made Tevimbra available at no cost to select esophageal cancer patients through its compassionate use program (EAP, Expanded Access Program). It remains to be seen if Tevimbra will make it onto the reimbursement list after completing discussions with the Pharmacoeceonic Evaluation Subcommittee, Risk Sharing Subcommittee, and Drug Reimbursement Evaluation Committee. Tevimbra extended the median overall survival (OS) by 2.3 months compared to chemotherapy (8.6 months vs. 6.3 months) in the global Phase III RATIONALE-302 trial, statistically significantly reducing the risk of death by 30%. In the trial, Tevimbra demonstrated more than a twofold increase in the proportion of patients who responded to treatment compared to chemotherapy (20% vs. 10%), and the median duration of response was extended by about 3 months from 4.0 months to 7.1 months, showing a sustained response. Based on such results, the U.S. National Comprehensive Cancer Network (NCCN) recommended Tevimbra as a preferred option for the second-line treatment of esophageal squamous cell carcinoma at a high level (Category 1) in its revised treatment guidelines.
- Company
- Opdivo prolongs survival in urothelial carcinoma
- by Whang, byung-woo Feb 18, 2025 05:53am
- The emergence of new drugs such as immuno-oncology drugs in the first-line treatment of urothelial carcinoma, have refined treatment strategies in the area. With the number of options available in the clinical setting increasing, there is also growing concern over when and which treatment to select for the patients. However, experts believe that the choice of treatment that can maximize the effectiveness of the treatment is important, as the prognosis of urothelial carcinoma is still worse than that of other urologic cancers. Jong Jin Oh, Professor of Urology, Seoul National University Bundang Hospital Professor Jong Jin Oh, Professor of Urology at Seoul National University Bundang Hospital, who has the latest knowledge in the field, emphasized the need for institutional support for the emergence of new drugs that prolong the overall survival of patients with urothelial carcinoma. Urothelial carcinoma is a cancer that starts in the urothelial cells that line the inside of the bladder, and 90% of tumors that occur in the urinary tract are urothelial carcinoma. It is the most common type of bladder cancer, accounting for about 90% of all bladder cancer diagnoses. Even if patients undergo surgery, their life expectancy is not long, and the average overall survival period is just over one year, especially for patients with metastases. “In the first diagnosis, about 10% of patients with metastatic urothelial carcinoma are confirmed to have metastatic disease, and if adding patients whose cancer progressed or metastasized, 20-30% of all patients are confirmed to have metastatic disease,” said Professor Oh. “There may be microscopic metastases that are not detected by imaging tests, so the actual proportion of metastatic urothelial carcinoma may be higher than the confirmed proportion.” The chemotherapy combination of cisplatin and gemcitabine (GemCis) had been the representative treatment option. However, Professor Oh explained that the combination had clear limitations, such as response rate and toxicity. “The percentage of patients responding to gemcitabine is not high, and the duration of response is very short, less than a year, and the toxicity is strong, so patients cannot continue treatment for a long time,” said Professor Oh. ”Since urothelial carcinoma is a tumor that occurs in the urinary tract, many patients have reduced renal function, such as by having their kidneys or bladder removed.” The emergence of immune checkpoint inhibitors for urothelial carcinoma is expected to extend survival In this situation, the emergence of new drugs, including immune checkpoint inhibitors, is expected to extend patient survival. One of the recent changes is the approval of Opdivo (nivolumab) in combination with cisplatin and gemcitabine as a first-line treatment for unresectable or metastatic urothelial carcinoma in July. Looking at the Phase III CheckMate-901 trial, which was the basis for the approval of Opdivo, at a median follow-up period of 33.6 months, the median overall survival (mOS), the primary endpoint, was 21.7 months with the combination of Opdivo and chemotherapy, which was significantly longer than the 18.9 months with the combination of cisplatin and gemcitabine, and reduced the risk of death by 22%. “Opdivo is the first immuno-oncology drug approved for the first-line treatment of metastatic urothelial carcinoma. The combination of Opdivo and gemcitabine has extended the overall survival by about 3 months compared to the existing gemcitabine monotherapy,” said Professor Oh. ”This means that we have an opportunity to extend the expected life expectancy that has been around one year with the existing treatment to about one and a half years.” So, how has the actual prescription experience been for domestic patients? Professor Oh expected that Opdivo would play a role in the situation where most patients with metastatic urothelial carcinoma first experience lymph node metastasis. He said, “In the subgroup with lymph node-only metastases, the rate of complete remission of metastatic lesions was much higher with Opdivo than with gemcitabine therapy, and the duration was also much longer. As the study confirmed very good effects, I think it is an effective treatment that can be considered as a first-line treatment for patients with lymph node metastases. In fact, in the CheckMate-901 subgroup analysis, patients with lymph node-only metastases were compared between the combination of Opdivo and gemcitabine and Gemcitabine alone, and the median overall survival was 46.3 months for the combination of Opdivo and gemcitabine and 24.9 months for gemcitabine alone. In response, Professor Oh said, “Lymph nodes are where the immune response is most active in our bodies, so it is thought that their response rate to immuno-oncology drugs such as Opdivo will be high. Patients with cancer that has spread to other organs have a much lower level of activity, but patients with lymph node-only metastasis have a relatively good overall condition, which may have a positive impact on treatment outcomes as they can receive treatment as planned. In conclusion, in the first-line treatment of metastatic urothelial carcinoma, if the patient has a low tumor burden or lymph node metastasis alone, Professor Oh believes the relatively less toxic Opdivo-Gemcitabine regimen may be a useful option among the first-line treatment options. "Will increase Opdivo’s use in lymph node metastasis alone and as adjuvant therapy" In particular, Professor Oh focused on Opdivo’s use as adjuvant therapy based on the CheckMate-274 study. “Currently, the standard adjuvant therapy for urothelial carcinoma is GemCis, but there are cases where patients undergo surgery after chemotherapy and the results of the biopsy are not good. In this case, the effectiveness of adjuvant gemcitabine therapy is low, and the disease usually recurs within 6 months,” explained Professor Oh. “Since other therapies that can be tried outside of standard treatment for GemCis have not yet been established, this is a very unfavorable case, and we expect that the post-operative adjuvant therapy of Opdivo will be used most actively in such patients.” However, Opdivo as adjuvant therapy for urothelial carcinoma is not reimbursed by Korea’s health insurance. Professor Oh stressed the need for reimbursement of new drugs that can benefit patients with urothelial carcinoma, who have a short overall survival period and therefore are in urgent need of treatment. He said, “For patients with poor post-operative biopsy results, we are trying to use Opdivo as adjuvant therapy if conditions permit. Since there is no alternative to adjuvant Opdivo therapy, patients are very desperate so healthcare professionals believe the drug is absolutely necessary.” Finally, Professor Oh said, “The complete remission rate is about 40-50% with standard chemotherapy, but it can be improved to 60-70% with new drugs. I see the significance of its use as adjuvant therapy, and I hope that many patients will be able to use the drug without burden through prompt reimbursement.”
- Company
- Samsung Bioepis’s Prolia and Xgeva biosimilars approved
- by Chon, Seung-Hyun Feb 18, 2025 05:53am
- Pic of Samsung Bioepis Headquarters Samsung Bioepis' two bone disease treatment biosimilars have passed the US and European hurdles. Samsung Bioepis announced on the 16th that it has obtained marketing authorizations for its two biosimilar versions of Prolia and Xgeva, which are bone disease treatments, from the US Food and Drug Administration (FDA) and the European Commission (EC). Prolia and Xgiva are biopharmaceuticals developed by Amgen, and the two were developed by varying the dose and dosage cycle of the main ingredient, denosumab. Prolia is used as a treatment for osteoporosis, and Xgeva is approved for the prevention of skeletal system symptoms in patients with bone metastases and the treatment of giant cell tumors of bone. Last year, global sales of Prolia and Xgeva reached a total of USD 6.599 billion (KRW 9.7 trillion). Samsung Bioepis obtained separate marketing authorizations for each indication, just like the original drug. The Prolia biosimilar was licensed under the brand name Ospomyv in the US and Obodence in Europe. The Xgeva biosimilar was licensed under the name Xbryk in both the US and Europe. Samsung Bioepis has successfully commercialized 10 biosimilar products in the United States and 11 in Europe. A Samsung Bioepis official said, “We will continue to work to meet the unmet medical needs of patients around the world through the development of biosimilars in various disease areas.”
- Company
- Celltrion gains EU approval for Eylea biosimilar Eyedenzelt
- by Chon, Seung-Hyun Feb 17, 2025 05:53am
- On February 14, Celltrion announced that it had secured the marketing authorization for the Eylea biosimilar Eyedenzelt from the European Commission. Two months after receiving the recommendation for marketing authorization from the European Medicines Agency (EMA)'s Committee for Medicinal Products for Human Use (CHMP) in December, the drug was granted the final approval. Eyedenzelt is approved for the original drug's major indications to treat wet (neovascular) age-related macular degeneration (wAMD), retinal vein occlusion, diabetic macular edema (DME), and myopic choroidal neovascularization. In 2023, Eylea recorded sales of approximately KRW 13 trillion globally. Celltrion confirmed the equivalence of Eyedenzelt compared to the original drug based on the global phase 3 trials involving 348 patients with DME. Celltrion obtained approval from the Ministry of Food and Drug Safety (MFDS) in May and is currently working on the sales. In December, Celltrion received a recommendation from the EMA's CHMP for European marketing authorization of biosimilars, including Eyedenzelt, Actemra, Prolia, and Xgeva. Celltrion plans to expand its biosimilar portfolio to bone diseases and eye diseases, in addition to previously established autoimmune diseases and anticancer agents, through the approval of biosimilars, including Eyedenzelt. "Given the marketing authorization of Eyedenzelt, we can now expand product portfolio areas in the European market and speed up the launch in the global market," a Celltrion representative said. "As we expect to secure more approvals through the marketing authorization recommendation for biosimilars, Celltrion will strive to quickly launch the products and strengthen strategies to gain market dominance."
- Company
- COVID-19 vaccination and corporate productivity
- by Whang, byung-woo Feb 17, 2025 05:53am
- A study has been published showing that although the COVID-19 pandemic has transitioned into the post-COVID-19 era, there is a significant difference in productivity loss depending on whether or not one has been vaccinated. Analysis showed that the productivity loss caused by not receiving COVID-19 vaccination amounts to about KRW 5.6 trillion, which is more than 3 times the medical expense. Hankil Lee, Professor of College of Pharmacy at Ajou University On the 14th, Hankil Lee, a professor at the College of Pharmacy at Ajou University Hospital, who presented on the topic of “The Losses Caused by COVID-19 and the Socio-Economic Impact of Vaccination,” said that COVID-19 infections are still causing serious socioeconomic losses. Five years after the World Health Organization (WHO) declared COVID-19 a pandemic, various assessments are being made on the economic impact of COVID-19. The research presented on this day was conducted by the College of Pharmacy at Ajou University and analyzed the socioeconomic effects of COVID-19 vaccinations. First, a domestic study (based on the National Health Insurance Service's big data) that estimated productivity losses and medical expenses for the employed population found that the social loss caused by COVID-19 in 2023 amounted to about KRW 7 trillion. Specifically, of the 25.16 million employed people aged 18-64, about 9.8 million received outpatient care, about 140,000 received inpatient care, and 1,539 died. Based on this, the estimated direct medical expenses were about KRW 1.4 trillion, of which outpatient care costs were KRW 540 billion, inpatient care costs were KRW 220 billion, and sequelae treatment costs were KRW 450 billion. The key to the study is how much COVID-19 vaccinations can reduce such socio-economic losses. A research team at Ajou University analyzed the effects of COVID-19 vaccination on 10,000 employees of a large Korean company (Samsung Electronics) and found that the vaccination could reduce medical expenses and productivity losses. The research results showed that the COVID-19 vaccine Spikevax JN.1 from Moderna reduced medical expenses and productivity losses by KRW 1.1 billion per 10,000 employees. When this is converted to the total 120,000 employees of the company, it is estimated that the cost savings can amount to KRW 13 billion. In addition, assuming that the cost of employing one employee was KRW 120 million, the loss of productivity for the company when an employee did not get vaccinated was KRW 340 million, but when the vaccination rate reached 70%, the loss decreased to KRW 240 million, resulting in an economic gain of KRW 160 million. “This is the first study to estimate the socioeconomic costs of COVID-19 infections from a national perspective using the latest data sources in Korea,” said Professor Lee. ”Looking at the trend in COVID-19 infection rates in 2024, the scale of productivity losses is expected to increase further.” Lee added, “COVID-19 infection is still causing serious socioeconomic burdens, and vaccination of employees may be an effective strategy to reduce corporate losses and cut costs.”
- Company
- Vyloy with CDx issue resolved will launch in March
- by Whang, byung-woo Feb 17, 2025 05:52am
- The gastric cancer treatment Vyloy (zolbetuximab), which overcame the issue of companion diagnostics, will soon challenge the market. Reimbursement coverage with the National Health Insurance remains to be solved, but it has already received favorable assessments in the clinical practices. Despite launching as a non-reimbursed drug, it is likely to be prescribed more frequently. On February 14, Astellas Pharma Korea hosted a press conference to announce the launch of its claudin-18.2-targeting gastric cancer therapy, Vyloy. Dr. Sun Young Rha, Professor in the Department of Oncology at Younsei Cancer Center.Vyloy is a first-in-class treatment for patients with HER2-negative gastric cancer as a first-line treatment. It is the world's first anticancer agent to target claudin-18.2. In South Korea, Vyloy was approved by the Ministry of Food and Drug Safety (MFDS) as a 'First-line treatment in combination with fluoropyrimidine- and platinum-containing chemotherapy for patients with claudin-18.2-positive, HER2-negative unresectable, locally advanced, or metastatic gastric adenocarcinoma or esophageal cancer.' Dr. Sun Young Rha, Professor in the Department of Oncology at Younsei Cancer Center, Vyloy, who was the presenter for the event, said, "About 90% of the patients with metastatic gastric cancer are found to be HER2-negative. Therefore, patients were desperate for a medicine that targets a new biomarker." Dr. Rha explained, "About 40% of the HER2-negative patients are reported to be claudin-18.2-positive. Vyloy, which selectively targets claudin-18.2, introduced a new treatment option." The basis of Vyloy approval, the Phase 3 SPOTLIGHT trial showed that the median progression-free survival (mPFS) of a combination therapy containing mFOLFOX6 (oxaliplatin, leucovorin, 5-Fluorouracil, leucovorin) was 10.61 months, which was higher than 8.67 months of the placebo group. The medial overall survival (OS) was 18.23 months, higher than 15.54 months of the placebo group. In the GLOW study, the patient group treated with Vyloy in combination with CAPOX (oxaliplatin and capecitabine) recorded a mPFS of 8.21 months, which lowered the disease progression or death risk by approximately 31%. Despite these results, Vyloy's launch in South Korea had been postponed due to the issue of companion diagnostics last year. At that time, claudin-18.2-positive patients needed to be identified for the use of Vyloy. CDx used to diagnose Claudin-18.2 has been considered for evaluation as a new healthcare technology. After that, it was reviewed by the expert committee twice, and CDx was determined to be an existing technology. Consequently, Vyloy has been scheduled to launch on March 3. Dr. Hye Seung Lee, Professor in the Department of Pathology at Seoul National University Hospital, said, "Claudin-18.2 protein targeted by Vyloy is specifically expressed in certain cancer types, such as gastric cancer. It provides high specificity towards abnormal cells." Lee added, "Consistent results can be obtained, and fast analysis can be achieved with claudin-18.2, so we can quickly identify the patient group with expected treatment effects." The remaining issue is the reimbursement. Astellas Pharma Korea plans to secure reimbursement soon. However, at its first meeting for 2025 on February 12, the Cancer Disease Review Committee (CDRC) decided that 'reimbursement criteria are not set' for Vyloy. Dr. Rha said, "Obtaining reimbursement will not be easy, but there are only a few treatments with such benefits for gastric cancer. We are considering ways to build data to identify the drug's effectiveness in Korean patients." Regarding this, before the approval of Vyloy, Astellas Pharma Korea has been openly providing the EAP program openly so that patients who need the treatment can use the drug promptly. Currently, 51 patients have been registered in 10 medical centers. Astellas Pharma Korea representative said, "The clinical usefulness of Vyloy is non-debatable, and the company is preparing with utmost efforts for the cost aspect." Adding, "How the drug is used in clinical practices is also important; thus, by collaborating with institutes participating in the EAP program, we will strive to build data so that patients can benefit clearly."
- Company
- Columvi can be prescribed at Big 5 hospitals in KOR
- by Eo, Yun-Ho Feb 17, 2025 05:52am
- ‘Columvi,' the first bispecific antibody treatment option for lymphoma, may be prescribed at general hospitals in Korea. According to industry sources, Roche Korea's CD20-CD3 bispecific antibody for diffuse large B-cell lymphoma (DLBCL) Columvi (glofitamab) has passed the drug committees (DCs) of the Big 5 general hospitals in Korea, including Samsung Medical Center, Seoul National University Hospital, Asan Medical Center, Seoul St. Mary's Hospital, and Sinchon Severance Hospital. However, Columvi is currently a non-reimbursed drug. Its reimbursement application was reviewed by the Health Insurance Review and Assessment Service’s Cancer Disease Deliberation Committee in July and December but was unable to set reimbursement standards at the time. Since prescription codes have been generated for the drug in many medical institutions, it will be interesting to see if Columvi can complete the reimbursement process within the year. Columvi was approved in Korea in December 2023 for the treatment of adult patients with relapsed or refractory diffuse large B cell lymphoma (DLBCL), after two or more lines of systemic therapy. The drug is a third-line treatment option for DLBCL, like Novartis’s chimeric antigen receptor (CAR)-T-cell therapy Kymriah (tisagenlecleucel). The two drugs have different benefits; therefore the choice will likely be based on each patient's condition and circumstance. Columvi demonstrated efficacy in Phase I/II NP30179 trial in 155 patients with relapsed or refractory DLBCL after two or more prior systemic therapies. Results showed that Columvi achieved a complete response (CR) of 40% and an overall response rate(ORR) of 52%. The efficacy was also consistent across all subgroups. The most common adverse event was cytokine release syndrome (CRS). At the 2024 Congress of the European Hematology Association (EHA 2024), the company unveiled the results of the Phase III STARGLO study, which demonstrated an improvement in overall survival (OS) with Columvi. The STARGLO study enrolled patients with relapsed or refractory (R/R) diffuse DLBCL who were not eligible to receive an autologous stem cell transplant after one or more prior systemic therapies, or who had received two or more prior systemic therapies. In the primary analysis (median follow-up 11.3 months), Columvi and gemcitabine+oxaliplatin (GemOx) combination significantly improved the primary endpoint of OS with a 41% lower risk of death compared to rituximab+GemOx. Seok Jin Kim, Professor of Hematology and Oncology at Samsung Medical Center, said, "There had been much unmet need in DLBCL for more effective third-line treatment options for patients who fail first-line or experience repeated relapses. We expect the introduction of Columvi to significantly improve the outcomes for patients with relapsed or refractory lymphoma in Korea."
- Company
- Expanded indication sought for Novartis 'Kisqali' in KOR
- by Eo, Yun-Ho Feb 14, 2025 05:58am
- Product photo of Kisqali Early breast cancer indication of a CDK4/6 inhibitor 'Kisqali' is expected to be introduced in South Korea. According to industry sources, Novartis has recently submitted an application to the Ministry of Food and Drug Safety (MFDS) for Kisqali (ribociclib)'s expanded indication to treat early breast cancer. It is currently being reviewed for approval. Early breast cancer indication for Kisqali was approved in the United States and Europe in September and November last year, respectively. Once it's approved in South Korea, the competition against Lilly Korea's Verzenio (abemaciclib) is expected to expand. Verzenio is currently seeking reimbursement for early breast cancer. Kisqali was demonstrated to improve survival in hormone-positive/HER2-negative (HR+/HER2-) early breast cancer. The 4-year follow-up NATALEE study of Kisqali was presented during the recent European Society for Medical Oncology Congress 2024 (ESMO Congress 2024), showing its benefits. The 4-year landmark analysis results from the NATALEE study showed that during the median value of 44.2 months, the Kisqali combination therapy group had invasive Disease Free Survival (iDFS) of 88.5%, which was 4.9% higher than 83.6% of the group treated with endocrine therapy alone. Previously, in the 3-year analysis result, the Kisqali combination therapy group and endocrine therapy alone group had 90.8% and 88.1%, respectively. Considering that the two groups showed a difference of 2.7%, Kisqali's effect on reducing the risk of relapse has increased. However, it would require more time to accumulate further evidence on overall survival (OS). During the follow-up period of a median value of 44.2 months, mortality events showed no statistical difference due to few instances. However, the Kisqali group showed a slightly more positive trend. Meanwhile, regarding early breast cancer indication, Verzenio's first attempt to be considered for the Cancer Disease Review Committee (CDRC) of the Health Insurance Review and Assessment Service (HIRA) has been uneasy. After 6 months of waiting after submitting a reimbursement document, Verzenio was reviewed in May 2023, but the result was 'reimbursement criteria not set.' Five months later, Lilly reapplied for reimbursement to the HIRA in October. The drug was considered for the CDRC review in March 2024, but the result was the same. After that, Lilly again applied for the reimbursement and is awaiting the CDRC review date.
