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FDA approves Cabometyx for untreated advanced renal cell carcinoma
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The FDA approved cabozantinib for patients with previously untreated renal cell carcinoma, according to the agent’s manufacturer.
Cabozantinib (Cabometyx, Exelixis) — a small molecule inhibitor of the MET, AXL and VEGFR2 tyrosine kinases — received FDA approval last year for treatment of patients with advanced renal cell carcinoma who underwent prior antiangiogenic therapy.
“Today’s approval of Cabometyx is a true win for patients in the U.S. with advanced renal cell carcinoma who now have a new first-line treatment option,” Michael M. Morrissey, PhD, president and CEO of Exelixis, said in a company-issued press release. “We are very pleased with the expanded indication and are prepared to bring Cabometyx to all eligible patients who may benefit from this important treatment option.”
The FDA based the expanded approval of cabozantinib on results of the randomized phase 2 CABOSUN trial, which assessed cabozantinib vs. sunitinib (Sutent, Pfizer) as initial targeted therapy for patients with poor- or intermediate-risk clear-cell metastatic renal cell carcinoma.
Researchers randomly assigned 79 patients to 60 mg cabozantinib daily. The other 78 patients received 50 mg sunitinib daily, administered on a 4-weeks-on, 2-weeks-off schedule.
Investigator-assessed PFS analysis presented at last year’s ESMO Congress showed cabozantinib was more effective than sunitinib (median, 8.2 months vs. 5.6 months; HR = 0.66; 95% CI, 0.46-0.95).
At ESMO this year, PFS analyses per blinded independent radiology committee showed cabozantinib significantly prolonged median PFS compared with sunitinib (8.6 months vs. 5.3 months; HR = 0.48; 95% CI, 0.31-0.74). Results showed consistent benefit across subgroups based on International Metastatic Renal Cell Carcinoma Database risk group and presence of bone metastases.
Grade 3 or grade 4 adverse reactions occurred among 68% of patients who received cabozantinib and 65% of patients who received sunitinib. The most common grade 3 or grade 4 adverse events reported in the cabozantinib group included hypertension, diarrhea, hyponatremia, hypophosphatemia, palmar-plantar erythrodysesthesia, fatigue, increased alanine aminotransferase levels, decreased appetite, stomatitis, pain, hypotension and syncope.
A comparable percentage of patients in each group discontinued treatment due to adverse events (21% for cabozantinib vs. 22% for sunitinib).
“The CABOSUN trial enrolled treatment-naive patients with advanced kidney cancer, including those who are known to fare poorly, such as patients with intermediate- or poor-prognostic factors and those with bone metastases or multiple sites of metastatic disease,” Toni K. Choueiri, MD, director of Lank Center for Genitourinary Oncology at Dana-Farber Cancer Institute and a researcher on the CABOSUN trial, said in the release. “Physicians are already experienced in using Cabometyx in the second-line advanced renal cell carcinoma setting, and it is a much-needed advance to also now have Cabometyx as an option for their patients with previously untreated advanced [disease].”