FDA D.I.S.C.O. Burst Edition: FDA approval of Cabometyx (cabozantinib) for locally advanced or metastatic differentiated thyroid cancer
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 another recent FDA cancer drug approval.
On September 17, 2021, the FDA approved cabozantinib, brand name Cabometyx, for adult and pediatric patients 12 years of age and older with locally advanced or metastatic differentiated thyroid cancer that has progressed following prior VEGFR-targeted therapy and who are ineligible or refractory to radioactive iodine.
Efficacy was evaluated in COSMIC-311, a randomized 2:1, double-blind, placebo-controlled, multicenter clinical trial in patients with locally advanced or metastatic differentiated thyroid cancer that had progressed following prior VEGFR-targeted therapy and were ineligible or refractory to radioactive iodine.
The primary efficacy outcome measures were progression-free survival in the intent-to-treat population and overall response rate in the first 100 randomized patients, assessed by a blinded independent radiology review committee per RECIST 1.1. CABOMETYX significantly reduced the risk of disease progression or death versus placebo. The median progression-free survival was 11 months in the cabozantinib arm compared to 1.9 months for those receiving placebo. The overall response rate was 18% and 0% in the cabozantinib and placebo arms, respectively.
The most common adverse reactions with an incidence of greater than 25% were diarrhea, palmar-plantar erythrodysesthesia, fatigue, hypertension, and stomatitis. A warning was added for hypocalcemia.
This review used the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment. The FDA approved this application 2 months 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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