Oct. 5 Quick Takes: FDA panel declines to back Lumakras

FDA’s Oncolytic Drugs Advisory Committee voted 10-2 that progression-free survival data from the confirmatory CodeBreaK 200 study of Lumakras sotorasib from Amgen Inc. (NASDAQ:AMGN) could not readily be interpreted. The vote puts conversion of the drug’s accelerated approval in previously treated non-small cell lung cancer (NSCLC) — and Amgen’s leading position in the KRAS G12C market — at risk. The vote followed concerns raised in FDA briefing documents that included study bias due to early dropouts in the control arm and questions of data integrity related to inconsistencies between investigator and blinded reviewer assessments of progression, which could not be overcome due to a small effect size. In the confirmatory trial, patients in the Lumakras arm achieved a statistically significant increase in mPFS (5 weeks) over docetaxel control, but the PFS benefit was shorter than the six-week standard imaging interval.

FDA said during the meeting that a lack of conversion from accelerated to full approval would not necessarily lead to an immediate market withdrawal. The agency may request an additional trial, or could convert the accelerated approval based on data from the ongoing CodeBreaK 202 study in first-line NSCLC. Shares of Amgen were off $0.36 to $265.08 on Thursday. ...