MRK
FDA says: not so fast
Merck and Daiichi Sankyo voluntarily withdrew their U.S. Biologics License Application for ifinatamab deruxtecan, the lung cancer drug it had been pitching for accelerated approval in extensive-stage small cell lung cancer. The move came after conversations with the FDA, which basically signaled that the current package of data wasn’t enough to get the fast lane.
Why investors should care
This is the annoying kind of biotech moment where the science may still be interesting, but the paperwork says “come back later.” Merck had been leaning on phase 2 data showing a confirmed objective response rate of 48.2% in the broader study, with even stronger numbers in a second-line subset. But for accelerated approval, regulators want enough confidence to move before the final chapter is written — and the agency wasn’t sold.
The bigger story: the drug isn’t dead
The withdrawal doesn’t kill the program. Phase 3 IDeate-Lung02 is still enrolling, and Merck/Daiichi are also testing the drug in prostate and esophageal cancers. In other words, the company just lost a shortcut, not the whole highway.
And because Merck loves a plot twist...
The same story also included a separate licensing deal with SciBrunch Therapeutics for SPR2015, a preclinical KRAS G12D inhibitor. Merck agreed to pay $400 million upfront, with total potential value topping $2.13 billion — a reminder that Big Pharma never really leaves the shopping mall. It just walks out of one store and into another.
Big picture: the FDA withdrawal is a near-term hiccup for Merck’s oncology ambitions, but the company is still very much playing offense on cancer. The question is whether the next swing is a home run — or just another expensive at-bat.