Opdivo plus Cabometyx approved in the EU for advanced renal cancer
1st April 2021
The European Commission (EC) has authorised Bristol Myers Squibb’s (BMS) Opdivo plus Ipsen’s Cabometyx as a first-line treatment for advanced renal cell carcinoma (aRCC).
The EU approval is based on results from the Phase III CheckMate-9ER trial, which evaluated Opdivo (nivolumab) in combination with Cabometyx (cabozantinib) in previously untreated advanced or metastatic renal cell carcinoma patients.
In this study, Opdivo plus Cabometyx doubled progression-free survival compared to patients receiving Pfizer s tyrosine kinase inhibitor (TKI) Sutent (sunitinib) alone – 16.6 months versus 8.3 months respectively.
The Opdivo and Cabometyx combination also reduced the risk of death by 40% compared to the TKI inhibitor, and also demonstrated a superior objective response rate (ORR) – twice as many patients responded to BMS/Ipsen’s drugs compared to Sutent.
Merck Receives Priority Review From FDA for New Drug Application for HIF-2? Inhibitor Belzutifan
Application Based on Objective Response Rate From Phase 2 Trial Evaluating Belzutifan in Patients With Von Hippel-Lindau Disease-Associated Renal Cell Carcinoma New Filing Further Strengthens Merck’s Expanding and Diverse Oncology Portfolio Merck known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration has accepted and granted priority review for a New Drug … Application Based on Objective Response Rate From Phase 2 Trial Evaluating Belzutifan in Patients With Von Hippel-Lindau Disease-Associated Renal Cell Carcinoma New Filing Further Strengthens Merck’s Expanding and Diverse Oncology Portfolio
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Glenmark
Glenmark launches SUTIB (Sunitinib) - priced 96% lower than the innovator brand- Reduces the risk of kidney cancer progression by 58% ANI | Updated: Feb 16, 2021 12:24 IST
Mumbai (Maharashtra) [India], February 16 (ANI/PRNewswire): Glenmark Pharmaceuticals, a research-led, global integrated pharmaceutical company, today launched SUTIB, the generic version of Sunitinib oral capsules to treat kidney cancer in India.
The drug is launched at a MRP that is approx. 96 per cent lower than the MRP compared to the innovator brand, priced at Rs 7000 (50 mg), Rs 3600 (25 mg) and Rs 1840 (12.5 mg) per month. Sunitinib is also approved by the US Food and Drug Administration (US FDA).
Kidney cancer (renal cell carcinoma) is a disease of uncontrolled cell growth in the lining of small tubes in the kidney. In the past decade, advances in research and drug development have begun to shift the paradigm of this disease.
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Cabozantinib (Cabometyx) came out on top as upfront therapy in metastatic papillary renal cell carcinoma (RCC) in a randomized phase II study.
Treatment with the multikinase inhibitor yielded a median progression-free survival (PFS) of 9.0 months, as compared to 5.6 months with sunitinib (Sutent), which has been the default standard of care in this setting (HR 0.60, 95% CI 0.37-0.97, one-sided
P=0.019), reported Sumanta Pal, MD, of City of Hope Comprehensive Cancer Center in Duarte, California.
Overall response rate was significantly improved with cabozantinib compared with sunitinib (23% vs 4%,
P=0.01), and 5% versus none, respectively, had complete responses, according to findings presented at the virtual Genitourinary Cancers Symposium (GUCS) and published simultaneously in the