Lack Of Comparative Trials Stymied BMS’s EU Filings For Opdivo In Colorectal, Liver Cancers
Bristol-Myers Squibb’s decision to withdraw its EU application to extend Opdivo’s use to metastatic colorectal cancer (mCRC) follows a similar move for liver cancer last year. The company now seems to be more interested in pursuing the product’s use in combination with Yervoy and Mekinist in mCRC.
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The pharma hopes showing a PFS benefit in first-line NSCLC patients with a high tumor mutation burden may provide a way to compete with Merck in that setting, but analysts think it will need overall survival data.
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.
Response rate data supports yet another supplemental approval for Opdivo in an underserved tumor type that is becoming more competitive.