Welcome back to the D.I.S.C.O., FDA’s Drug Information Soundcast in Clinical Oncology, Burst Edition, brought to you by FDA’s Division of Drug Information in partnership with FDA’s Oncology Center of Excellence. Today we’ll provide a quick update on a recent FDA cancer drug approval.
On March 22, 2023, the FDA granted accelerated approval to retifanlimab-dlwr (brand name Zynyz) for adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma. Safety and efficacy were evaluated in PODIUM-201, an open-label, multiregional, single-arm study evaluating 65 patients with metastatic or recurrent locally advanced Merkel cell carcinoma who had not received prior systemic therapy for advanced disease.
The major efficacy outcome measures were objective response rate and duration of response assessed by an independent central review committee according to RECIST v1.1. The objective response rate was 52% with complete response rate of 18%. Twenty-six patients had a duration of response greater than or equal to 6 months and 21 patients had a duration of response greater than or equal to 12 months.
The safety population consisted of 105 patients with Merkel cell carcinoma. The most common adverse reactions occurring in more than 10% of patients were fatigue, musculoskeletal pain, pruritus, diarrhea, rash, pyrexia, and nausea. Serious adverse reactions occurred in 22% of patients receiving retifanlimab-dlwr.
This review used the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment.
Full prescribing information for these approvals can be found on the web at www.fda.gov/drugsatFDA.
Health care professionals should report serious adverse events to FDA’s MedWatch Reporting Program at www.fda.gov/medwatch.
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