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 January 26, 2023, the FDA approved pembrolizumab (brand name Keytruda) for adjuvant treatment following resection and platinum-based chemotherapy for stage IB, II, or IIIA non-small cell lung cancer.
FDA limited the indication to adult patients who received prior adjuvant chemotherapy.
Efficacy was evaluated in KEYNOTE-091, a multicenter, randomized, triple-blind, placebo-controlled trial. Patients had not received neoadjuvant radiotherapy or chemotherapy. Patients were randomized 1:1 to receive pembrolizumab 200 mg or placebo intravenously every 3 weeks for up to 1 year. Stratification factors included receipt of adjuvant chemotherapy and region of the world. Of the 1177 patients randomized, 1010 (or 86%) received adjuvant platinum-based chemotherapy following complete resection.
The major efficacy outcome measure was investigator-assessed disease-free survival. The trial met its primary endpoint, demonstrating a statistically significant improvement in disease-free survival in the overall population. In an exploratory subgroup analysis of the 167 patients who did not receive adjuvant chemotherapy, the disease-free survival hazard ratio was 1.25. For patients who received adjuvant chemotherapy, median disease-free survival was 58.7 months in the pembrolizumab arm and 34.9 months in the placebo arm; hazard ratio was 0.73.
The adverse reactions observed in KEYNOTE-091 were generally similar to those occurring in other patients with non-small cell lung cancer receiving KEYTRUDA as a single agent, with the exception of hypothyroidism, hyperthyroidism, and pneumonitis. Two fatal adverse reactions of myocarditis occurred.
This review was conducted under Project Orbis, an initiative of the FDA Oncology Center of Excellence. Project Orbis provides a framework for concurrent submission and review of oncology drugs among international partners. The application reviews are ongoing at the other regulatory agencies.
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 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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