Pfizer and Merck KGaA’s Bavencio is heading toward a piece of the crowded bladder cancer market that it can call its own.
The drug has nabbed the FDA’s breakthrough therapy designation as a treatment for bladder cancer patients whose disease hasn’t progressed after induction chemo, the companies said Monday, and on top of that, the agency is reviewing the application under its Real-Time Oncology Review program—meaning an approval could come quickly.
Regulators based their decision on data from the phase 3 Javelin Bladder 100 study, which the companies said in January had shown Bavencio could top best supportive care at lengthening patients’ lives. Detailed trial results still aren’t public, though Bavencio’s makers intend to change that at an upcoming medical meeting.
A new approval could give Bavencio a niche foothold in a bladder cancer arena that’s chock-full of competitors. Five of the six PD-1/PD-L1 drugs currently on the market are approved in metastatic bladder cancer, though none bear the first-line maintenance green light that Pfizer and Merck KGaA are gunning for.
And the drugmakers certainly wouldn’t mind a market all to themselves. Bavencio has so far fallen short of expectations, in part because of a number of failed trials across multiple tumor types, including ovarian cancer and stomach cancer. And in its other indications—Merkel cell carcinoma and kidney cancer—it's battling Merck powerhouse Keytruda.