FDA D.I.S.C.O. Burst Edition: FDA approval of Keytruda (pembrolizumab) for the adjuvant treatment of patients with renal cell carcinoma at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions
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 November 17, 2021, the FDA approved pembrolizumab (brand name Keytruda) for the adjuvant treatment of patients with renal cell carcinoma at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions.
Efficacy was evaluated in KEYNOTE-564, a multicenter, randomized 1:1, double-blind, placebo-controlled trial in 994 patients with intermediate-high or high risk of recurrence of renal cell carcinoma, or M1 no evidence of disease. Patients were randomized to pembrolizumab 200 mg intravenously every 3 weeks or placebo for up to 1 year until disease recurrence or unacceptable toxicity.
The major efficacy outcome measure was investigator-assessed disease-free survival, defined as time to recurrence, metastasis, or death. An additional outcome measure was overall survival. A statistically significant improvement in disease-free survival was demonstrated at a prespecified interim analysis, with 109 events in the pembrolizumab arm and 151 events in those receiving placebo. Median disease-free survival was not reached in either arm. At the time of the disease-free survival analysis, overall survival data were not mature, with 5% deaths in the overall population.
The most common adverse reactions reported in more than 20% of patients on this trial were musculoskeletal pain, fatigue, rash, diarrhea, pruritus, and hypothyroidism.
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 may be ongoing at the other regulatory agencies.
This review used the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment. The FDA approved this application 3 weeks ahead of the FDA goal date.
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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