Bavencio snags bladder cancer approval ahead of goal date
- Merck KGaA and Pfizer are finally joining the PD-1/L1 inhibitor scramble to the bladder cancer market with the U.S. accelerated approval of Bavencio (avelumab), bringing the drug to the market around three months ahead of its user fee goal date.
- The approval is for patients with locally advanced or metastatic urothelial carcinoma with progression during or following platinum-containing chemotherapy, and is based on an open-label Phase 1 study, JAVELIN.
- The partners will need to provide confirmatory data for full approval. A Phase 3 study, JAVELIN Bladder 100, is currently enrolling, and will compare Bavencio plus standard-of-care compared with standard-of-care alone in patients with locally advanced or metastatic urothelial carcinoma whose disease did not progress after first-line platinum-containing chemotherapy.
This is the second accelerated approval for Bavencio in less than two months; it snagged a thumb's up from the FDA for adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (MCC) in March, becoming the fourth checkpoint inhibitor to the market. MCC is one of the rarer cancers, but gave German Merck and Pfizer a leg-up into the PD-1/L1, which is starting to get a bit crowded.
Merck KGaA and Pfizer, who first hooked up over Bavencio in November 2014, are also pursuing the drug in similar markets to their checkpoint inhibitor competitors Merck & Co., Bristol-Myers Squibb, Roche and most recently AstraZeneca, who are piling up the approvals. Bavencio is under scrutiny for non-small cell lung cancer, gastric cancer, ovarian cancer, renal cell carcinoma and squamous cell carcinoma of the head and neck.
The approval comes the day before Roche announced a failure of its checkpoint inhibitor Tecentriq (atezolizumab) in second-line bladder cancer. The trial failure comes after Roche already gained accelerated approval for Tecentriq in both first-line and second-line bladder cancer. The failure calls into question the approval, as well as the validity of approving drugs under the accelerated process.
Bladder cancer is the sixth most common cancer in the U.S., and has a poor prognosis – metastatic bladder cancer has only a 5% five-year survival rate.
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