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FDA grants priority review to Keytruda as part of advanced kidney cancer regimen
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The FDA granted priority review for a supplemental biologics license application seeking approval of pembrolizumab in combination with axitinib for first-line treatment of patients with advanced renal cell carcinoma, according to a press release from the manufacturer.
The application is based on findings from the phase 3 KEYNOTE-426 trial, presented at Genitourinary Cancers Symposium, which showed pembrolizumab (Keytruda, Merck), an anti-PD-1 therapy, in combination with axitinib (Inlyta, Pfizer), a tyrosine kinase inhibitor, significantly improved OS and PFS as first-line therapy in patients with advanced renal cell carcinoma compared with pembrolizumab and sunitinib (Sutent, Pfizer).
“Many patients with advanced renal cell carcinoma face a poor prognosis and there remains a need for new and effective treatment options in the first-line setting,” Roger M. Perlmutter, MD, president of Merck Research Laboratories, said in a press release. “We look forward to working with the FDA to bring this Keytruda combination to patients.”
The FDA set a target action date of June 20.