After kickback from the FDA, Bristol-Myers yanks its Opdivo/Yervoy BLA for high TMB approach to lung cancer
Bristol-Myers Squibb has had a hard time winning analysts over to its strategy for carving out a higher market share for its checkpoint combo in non-small cell lung cancer. And now you can add the FDA to the list of skeptics requiring more data to convince them.
In their Q4 release Thursday morning Bristol-Myers Squibb says it is yanking its BLA for Opdivo combined with Yervoy for frontline NSCLC cases with high tumor mutational burden — or TMB — after talks with the agency convinced them they needed more data to highlight the connection between TMB and PD-L1.
Unlock this article instantly by becoming a free subscriber.
You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.