Biotech Values

[DewDiligence]

BMY—Do you anticipate approval in the US based on these results? I would be surprised if FDA allows this trial to support US approval, though this wouldn't be first time I've been surprised by FDA handling of IO drugs!

Second-line gastric cancer is an unmet medical need, but the phase-3 trial in question was limited to patients in Japan, Korea and Taiwan. So, data on non-Asian patients will probably be needed for FDA approval in this indication, but Opdivo will almost certainly get a label expansion in the countries mentioned above and perhaps other countries in Asia.

…there was no mention of bringing these data to health authorities or regulatory agencies in BMY's press release. The exclusion of such standard boilerplate language seems intentional to me, but I might be reading too much into it.

Normally, the inclusion or exclusion of such boilerplate language is a pretty reliable signal. However, for a US-based company, getting feedback from regulators in Japan, Korea, and Taiwan may be more cumbersome than getting feedback from the FDA, so BMY may be reticent about commenting on regulatory plans.