Pfizer, Merck KGaA clinch needed approval for Bavencio, directly competing against Keytruda in kidney cancer
Less than a month after Merck notched an early OK to market a Keytruda combo as frontline therapy for renal cell carcinoma, rivals Pfizer and Merck KGaA have arrived at the scene with its own FDA approval.
As is the case with Keytruda, their PD-L1 inhibitor Bavencio is sanctioned for use with Inlyta, a tyrosine kinase inhibitor from Pfizer. In the Phase III JAVELIN Renal 101 study, this combo demonstrated a significant progression-free survival benefit: five months across the intent-to-treat patient population compared to the comparator arm, who were given Sutent. That surpassed the expectations of investigators as they initially narrowed the focus to PD-L1 positive patients.
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