The U.S. Food and Drug Administration issued Incyte Corporation with a Complete Response Letter (CRL) over the company’s Biologics License Application (BLA) for retifanlimab for anal cancer.
The Oncologic Drugs Advisory Committee (ODAC), as part of the U.S. Food and Drug Administration, voted 13-4 that a regulatory decision on Incyte’s PD-1 inhibitor retifanlimab for the treatment of advanced or metastatic squamous cell carcinoma of the anal canal (SCAC) should be deferred until further data are available from the clinical trial POD1UM-303.
AstraZeneca and Merck announced positive five-year follow-up data from the Phase III SOLO-1 trial which demonstrated a long-term progression-free survival benefit of Lynparza as a first-line maintenance treatment in patients with newly diagnosed, advanced BRCA-mutated ovarian cancer who were in complete or partial response to platinum-based chemotherapy.
