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’ll provide a quick update on a recent FDA cancer drug approval.

On August 10, 2021, FDA approved the combination of lenvatinib (brand name Lenvima) plus pembrolizumab (brand name Keytruda) for first-line treatment of adult patients with advanced renal cell carcinoma.

The efficacy of this combination was investigated in CLEAR, a multicenter, open-label, randomized phase 3 trial in patients with advanced renal cell carcinoma in the first-line setting. Patients were enrolled regardless of PD-L1 tumor expression status. The efficacy population supporting this approval included patients randomized to lenvatinib plus pembrolizumab compared with those randomized to single-agent sunitinib.

Progression-free survival, assessed by independent radiologic review according to RECIST 1.1, and overall survival were the major efficacy endpoints. Patients receiving pembrolizumab with lenvatinib had a median progression-free survival of 23.9 months compared with 9.2 months for those receiving sunitinib. Median overall survival was not reached in either arm. The objective response rates were 71% and 36%; complete response rates were 16% and 4% on the combination and sunitinib arms, respectively.

The most common adverse reactions reported in more than 20% of patients who received lenvatinib and pembrolizumab in clinical trials were fatigue, diarrhea, musculoskeletal pain, hypothyroidism, hypertension, stomatitis, decreased appetite, rash, nausea, decreased weight, dysphonia, proteinuria, palmar-plantar erythrodysesthesia syndrome, abdominal pain, hemorrhagic events, vomiting, constipation, hepatotoxicity, headache, and acute kidney injury. Arterial thrombotic events occurred in 5% of patients in CLEAR, including myocardial infarction and cerebrovascular accident.

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. The FDA approved this application approximately 1 month ahead of the FDA goal date.

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 Program at www.fda.gov/medwatch.

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