BioCentury
ARTICLE | Product Development

March 11 Quick Takes: FDA’s ODAC to discuss PD-1/PD-L1 mAbs; plus Lilly, RemeGen, Idorsia and more

March 12, 2021 12:04 AM UTC

FDA’s Oncologic Drugs Advisory Committee will meet April 27-29 to review the status of PD-1 and PD-L1 inhibitors granted accelerated approval for breast, urothelial, gastric and hepatocellular cancers in light of confirmatory trials that have not verified clinical benefit. The meeting will cover Tecentriq atezolizumab from the Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY), Keytruda pembrolizumab from Merck & Co. Inc. (NYSE:MRK) and Opdivo nivolumab from Bristol Myers Squibb Co. (NYSE:BMY). 

U.K. grants conditional marketing authorization to Loxo’s Retsevmo
The U.K.’s MHRA granted conditional marketing authorization to Retsevmo selpercatinib from the Loxo Oncology unit of Eli Lilly and Co. (NYSE:LLY) as monotherapy for RET-driven non-small cell lung, thyroid and medullary thyroid cancers. The RET inhibitor is marketed as Retevmo in the U.S. for the same indications and received conditional approval by EMA last month. ...