BMS' Opdivo gets another lung cancer shot as FDA, EMA accept chemo combo filings

The FDA has set a decision date for August. (Bristol Myers Squibb)

Bristol-Myers Squibb’s Opdivo-Yervoy pairing is getting another shot at the previously untreated non-small cell lung cancer market.

Wednesday, the New Jersey drugmaker said regulators in the U.S. and EU had accepted applications for the duo, administered alongside two cycles of chemo, for first-line patients without EGFR or ALK mutations—and that the FDA had given the cocktail its priority review designation to boot.

RELATED: BMS' Opdivo-Yervoy duo nears its shot in first-line lung cancer with FDA 'priority' boost

The move sets Opdivo and Yervoy up for an FDA verdict by August 6, which could follow closely on the heels of another potential nod. The agency is currently evaluating the drugs without chemo in the same patient population, and after applying a priority tag to that filing, too, it set a decision date for May 15.

The positive news follows years of frustration for Bristol—which has tried and failed multiple times to snag a piece of the ultra-lucrative market—and its investors, who have watched archrival Keytruda from Merck gobble up share around the globe on the back of jaw-dropping data.

First came a failure for Opdivo monotherapy, and then later, a pulling of Opdivo-Yervoy filings based on investigational biomarker tumor mutational burden (TMB). And in Europe, the company also last month yanked its revamped Opdivo-Yervoy filing in Europe after regulators said multiple changes to BMS’ trial design had made it impossible to evaluate the data.

RELATED: BMS nets another Opdivo lung cancer win—but it still has to beat Merck's high bar

With its chemo-inclusive regimen, though, industry watchers are finally seeing some hope that Bristol can cross the finish line—and it might even dent Keytruda’s sales, some industry watchers predict. But that will all depend on the data the company comes up with, which hasn’t yet been publicly unveiled.

“The devil is in the details,” Leerink Partners analyst Daina Graybosch wrote in an October note to clients, following Bristol’s announcement that its trio had beaten placebo at extending patient lives. According to a Leerink survey, doctors are looking for median overall survival of at least 26 months, and/or a one-year survival rate of 77%, from the chemo-combo “to support widespread adoption.”

“We believe the triplet does have the potential to hit these marks, given the relatively long duration of therapy with Opdivo + Yervoy in 1L NSCLC … combined with more immediate tumor control of chemotherapy,” she wrote.