May 10, 2017 Source: pharmatimes 75
Merck and Pfizer have announced a second accelerated approval in the US for Bavencio in less than two months, in this instance for certain patients with metaqstatic urothelial carcinoma.
The green light from the US Food and Drug Administration allows physicians to prescribe the drug for patients with the condition during or after platinum-containing chemotherapy therapy, or who have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.
Bladder cancer makes up around 90 percent of urothelial carcinomas and is the sixth most common cancer in the US. The prognosis for patients with advanced disease is particularly bleak with a five-year survival rate of just 5 percent, highlighting the need to for new treatments options.
“Until recently, there had been limited innovation in urothelial carcinoma, and this approval gives us another treatment to help battle this aggressive disease,” said Dr Andrea Apolo, National Cancer Institute, Bethesda, US.
Bavencio (avelumab), a fully human anti-PD-L1 antibody, is already cleared for use to treat previously granted accelerated approval from the FDA for the treatment of adults and paediatric patients 12 years and older with metaqstatic Merkel cell carcinoma (MCC).
A full green light for both indications may be contingent upon verification and description of the drug’s clinical benefit in confirmatory trials.
Bavencio will be co-commercialised by EMD Serono, the biopharmaceutical business of Merck in the US and Canada, and Pfizer.
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