May 9 U.S. health regulators on Tuesday granted
accelerated approval for Pfizer Inc's immuno-oncology
drug Bavencio to treat advanced bladder cancer, marking the
second approval in less than two months for the treatment
developed along with Germany's Merck KGaA.
Bavencio, known chemically as avelumab, was approved for
patients with locally advanced or metastatic bladder cancer
whose disease progressed during or following platinum-containing
chemotherapy or within 12 months of chemotherapy treatment
before or after surgery.
The approval was based on response rates from a study of 242
patients who all received Bavencio. As a condition of
accelerated approval, the companies may be asked to conduct a
trial to confirm the benefits of the treatment.
In March, Bavencio was approved by the Food and Drug
Administration to treat a rare skin cancer called Merkel cell
Bavencio belongs to a class of drugs called PD-L1 inhibitors
that help the immune system to attack cancer by blocking a
mechanism tumors use to evade detection.
(Reporting by Bill Berkrot; Editing by James Dalgleish)