Drug Development

Why wait? FDA gives early OK to Merck’s Keytruda for frontline lung cancer

That didn’t take long.

Two weeks after Merck $MRK made a triumphant victory march against Bristol-Myers Squibb on the frontline non-small cell lung cancer front at ESMO, the FDA has followed up with a crucial approval for the early use of its checkpoint inhibitor Keytruda.

The agency green-lighted the use of Keytruda among high expressers of PD-L1, one of the key instruments that cancer cells use to deflect an attack by T cells. The FDA had set the PDUFA date on this sBLA for Christmas Eve, but regulators are moving much faster than the normal timelines permit when it comes to the established checkpoint drugs.

Keytruda is now the only PD-1 checkpoint inhibitor to be approved for frontline use, and patients who qualify won’t be forced to try chemo first. Merck’s unique status isn’t a permanent distinction, though, as Roche continues to push ahead with Tecentriq, a rival checkpoint designed specifically for high PD-L1 expression.

“Keytruda improved survival, compared to traditional chemotherapy, in patients with non-small cell lung cancer whose tumors express high levels of PD-L1,” said Roger M. Perlmutter, Merck’s R&D chief, who bet big on Keytruda’s success. “The approval of Keytruda for the first-line treatment of metastatic non-small cell lung cancer has the potential to change the treatment landscape for these patients.”

Bristol-Myers Squibb $BMY stumbled badly when it tried to beat out chemo as a frontline therapy for NSCLC. The top line data marked a failure, the details on subgroup flops were embarrassing. And the second round of data triggered another teeter-totter effect on their relative stock prices, driving BMS down while Merck continued its surge.

Bristol-Myers had dominated lung cancer from the get-go, earning the lion’s share of the first wave of revenue that greeted these two checkpoints. Now analysts say that the tables are being turned, giving Merck an edge that it has desperately sought after.

“We thought Opdivo could beat chemotherapy, and we have answered the question — for the broad population it is not enough,” Fouad Namouni, oncology development head at Bristol-Myers, told David Crow at the Financial Times at ESMO.


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RAPS Regulatory Convergence 2017