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. Recently we have another quick update on a recent FDA cancer drug approval.

On May 5, 2021, FDA granted accelerated approval to pembrolizumab (brand name Keytruda) in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of patients with locally advanced unresectable or metastatic HER2 positive gastric or gastroesophageal junction adenocarcinoma.

Approval was based on the prespecified interim analysis of the first 264 patients of the ongoing KEYNOTE-811 trial, a multicenter, randomized, double blind, placebo controlled trial in patients with HER2 positive advanced gastric or gastroesophageal junction adenocarcinoma who had not previously received systemic therapy for metastatic disease. Patients were randomized 1:1 to receive pembrolizumab or placebo every 3 weeks, in combination with trastuzumab and either fluorouracil plus cisplatin or capecitabine plus oxaliplatin.

The main efficacy measure for this analysis was overall response rate assessed by blinded independent review committee. The overall response rate was 74% in the pembrolizumab arm and 52% in the placebo arm. The median duration of response was 10.6 months for patients treated with pembrolizumab and 9.5 months for those in the placebo arm.

The adverse reaction profile observed in patients receiving pembrolizumab in the KEYNOTE-811 study was consistent with the known pembrolizumab safety profile.

This review used the Real-Time Oncology Review pilot program, which streamlined data submission prior to the filing of the entire clinical application, and the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment.

Full prescribing information for this approval can be found on the web at www.fda.gov/drugsatFDA.

Health care professionals should report serious adverse events to FDA’s MedWatch Reporting System at www.fda.gov/medwatch.

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