Opdivo approval might be good news for Astra

It might reassure AstraZeneca that the FDA on Thursday had no problem in approving Bristol Myers Squibb’s Opdivo for the periadjuvant treatment of non-small cell lung cancer. A recent adcom advised future applicants running studies that combine neoadjuvant with adjuvant treatment that these have to be designed in a way to gauge the individual contribution of each treatment stage – yet despite Bristol’s supporting Checkmate-77T trial not having such a design the agency has nodded it through. That’s good news because Astra’s Niagara study, in perioperative bladder cancer, impressed at ESMO, but it having a combined design might have raised questions about whether it could back approval; the FDA, in approving the latest Opdivo regimen, appears open to grandfathering in filings based on trials that started before its latest thinking evolved. That was also the case for Astra’s Aegean study, the subject of the July adcom. One difference for Bristol, however, is that Opdivo plus chemo is already separately approved for neoadjuvant NSCLC, so any added benefit Checkmate-77T shows can be gauged, albeit on a cross-trial basis. Though Astra has said it’s “sharing the Niagara data with regulators” there’s been no word on whether it has actually filed.

Opdivo in periadjuvant NSCLC

Source: OncologyPipeline.