FDA D.I.S.C.O. Burst Edition: Libtayo (cemiplimab-rwlc) for first-line treatment of patients with advanced NSCLC (locally advanced who are not candidates for surgical resection or definitive chemoradiation or metastatic) whose tumors have high PD-L1 expression with no eGFR, anaplastic lymphoma kinase or receptor tyrosine kinase aberrations
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 have another quick update on a recent FDA cancer drug approval.
On February 22, 2021, the FDA approved cemiplimab-rwlc (brand name Libtayo) for the first-line treatment of patients with advanced non-small cell lung cancer (locally advanced who are not candidates for surgical resection or definitive chemoradiation or metastatic) whose tumors have high PD-L1 expression (a Tumor Proportion Score greater than or equal to 50%) as determined by an FDA-approved test, with no estimated glomerular filtration rate, anaplastic lymphoma kinase or receptor tyrosine kinase aberrations.
Efficacy was evaluated in Study 1624, a multi-center, randomized, open-label trial in 710 patients with locally advanced non-small cell lung cancer who were not candidates for surgical resection or definitive chemoradiation or with metastatic non-small cell lung cancer. Patients were randomized 1:1 to receive cemiplimab-rwlc or a platinum-based chemotherapy.
The trial demonstrated statistically significant improvements in overall survival and progression-free survival for patients receiving cemiplimab-rwlc compared to those treated with platinum-based chemotherapy. Median overall survival was 22.1 months for patients in the cemiplimab-rwlc arm compared with 14.3 months in the chemotherapy arm. Median progression-free survival per blinded independent central review was 6.2 months in the cemiplimab-rwlc arm and 5.6 months in the chemotherapy arm. Confirmed overall response rate per blinded independent central review was 37% and 21% in the cemiplimab-rwlc and chemotherapy arms, respectively.
The most common adverse reactions occurring in more than 10% of patients with cemiplimab-rlwc as a single agent were musculoskeletal pain, rash, anemia, fatigue, decreased appetite, pneumonia and cough.
This review used 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 the FDA’s MedWatch Reporting System at www.fda.gov/medwatch.
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