Pfizer, Merck KGaA's Bavencio eyes speedy entry into untapped bladder cancer field

Bavencio could become the first drug in its class to enter the first-line bladder cancer maintenance market. (Pfizer/Merck KGaA)

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.

RELATED: Pfizer, Merck KGaA's Bavencio posts first-in-class bladder cancer win

Free Webinar

What could you do with real-time supply chain information at your fingertips?

Interested in complete supply chain real-time data visibility? Unlock productivity with digital workflows, manage plants inventory with real-time supply chain information and enable faster decision-making with data visualization with pci | bridge. Register today!

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.

RELATED: Pfizer, Merck KGaA scrap yet another Bavencio ovarian cancer trial

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.

Suggested Articles

Implementing data integration strategy in your commercialization breaks down traditional healthcare silos and improves patient outcomes.

Roche and Blueprint's RET inhibitor Gavreto has won FDA go-ahead to treat certain types of thyroid cancer, leveling the field with Lilly's Retevmo.

CDMO Sterling Pharma Solutions is plotting a buyout of a U.K.-based antibody-drug conjugate specialist in a new bid at the next-gen cancer fighters.