Opdivo’s EU Colorectal Cancer Setback ‘More Than Offset’ By Potential Gains In Combination
Bristol-Myers Squibb has withdrawn its EU application to extend Opdivo’s use to metastatic colorectal cancer (mCRC), following a similar move for liver cancer last year. But the mCRC withdrawal is likely to have limited commercial impact and the company is more interested in pursuing the product’s use in combination treatment for this indication.
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The recently launched Opdivo/Yervoy combination already has a leading position in first-line kidney cancer in the US – with a 30% share of new patients – but has been rejected in Europe.
US FDA's latest BTD awards go to Seattle Genetics and Astellas' antibody-drug conjugate for immunotherapy-experienced urothelial cancer, Fennec's supportive care product to reduce cisplatin ototoxicity in pediatric cancer patients, and Bristol's double immunotherapy combo in MSI-H colorectal cancer.
Seven Green Lights From EU’s CHMP, Including Drugs For Hemophilia, Diabetes, Alpha Mannosidosis And Hyperkalemia
The European Medicines Agency’s CHMP has OKd seven new products, including drugs for hemophilia A, diabetes, alpha mannosidosis, hyperkalemia and herpes zoster. But it again rejected Santhera’s filing for Raxone in the new indication of Duchenne muscular dystrophy, and also turned down Repros’ Encyzix for hypogonadism.