FDA accepts Bristol-Myers' Opdivo-Yervoy app in lung cancer, but without a speedy review

The FDA is set to make a decision on BMS' Opdivo-Yervoy combo by next February.

Bristol-Myers Squibb’s Opdivo is finally under FDA consideration as a therapy for previously untreated lung cancer, but it will still be a while before it can compete in the key market.

On Thursday, the agency said it had accepted Bristol’s application for a combination of PD-1 star Opdivo and fellow immunotherapy Yervoy in first-line, non-small cell lung cancer patients whose tumors bear high levels of new biomarker tumor mutational burden, or TMB. But it didn’t bestow a priority review on the combination, which would have hastened a verdict within six months’ time. Instead, it set a target decision date for Feb. 20 of next year.

BMS based the application on part 1 of its closely watched Checkmate-227 study, which back in April showed that after a minimum follow-up of 11.5 months, patients with high TMB receiving the Opdivo-Yervoy tandem were 42% less likely to see their disease worsen than those receiving standard-of-care treatment.

The same weekend, though, Merck archrival Keytruda posted data industry watchers deemed even more impressive. Keytruda, paired with chemo, slashed patients’ risk of death by 51%, and the tandem posted big benefits in patients regardless of their levels of the PD-L1 biomarker.

RELATED: BMS' Opdivo-Yervoy combo posts big win in first-line lung cancer—but big enough to challenge Merck?

As Bristol-Myers has contended, matching patients to treatments based on their specific biomarkers is important.

“This is a journey” of better understanding the biology of lung cancer “and having the right medicines for the right patients,” the company’s oncology development head, Fouad Namouni, M.D., said in an April interview.

RELATED: ASCO: Bristol-Myers racks up Opdivo combo data to sell its new biomarker, but will doctors buy it?

In order for that strategy to work, though, doctors will have to routinely test newly diagnosed lung cancer patients for TMB. And at a panel at the American Society of Clinical Oncology (ASCO) annual meeting earlier this month, presenting doctors “were all in agreement that TMB testing is not ready for routine clinical practice, recommending against testing all patients for it at this time,” Credit Suisse analyst Vamil Divan wrote in a note to clients.

In the meantime, while BMS waits for its shot at the lucrative front-line market, Merck will be using Keytruda’s chemo combo showing to further extend the drug’s lead in that space. The Keytruda-chemo marriage already bears an FDA green light in the population, which it picked up last May, and unlike Opdivo—which failed its shot at a monotherapy go-ahead—Keytruda boasts a monotherapy approval, too.