FDA approves Opdivo, Cabometyx combination for advanced kidney cancer

The FDA on Friday said it approved the combination of Bristol Myers Squibb's anti-PD-1 antibody Opdivo (nivolumab) and Exelixis' tyrosine kinase inhibitor Cabometyx (cabozantinib) as a first-line treatment for patients with advanced renal cell carcinoma (RCC). The application, which was assessed under a priority review as well as the FDA's Real-Time Oncology Review pilot programme, was cleared ahead of the February 20 action date.

The decision was backed by data from the Phase III CheckMate -9ER trial evaluating Opdivo plus Cabometyx against Pfizer's Sutent (sunitinib) in previously untreated advanced or metastatic RCC. Findings presented at the European Society for Medical Oncology (ESMO) last September showed that after a median follow-up of 18.1 months, patients treated with the combination achieved progression-free survival of 16.6 months, compared to 8.3 months for the Sutent arm. Opdivo plus Cabometyx also significantly reduced the risk of death by 40% compared to Sutent alone (for additional analysis, see KOL Views Results: Leading oncologist says QOL data from CheckMate-9ER may give Opdivo/Cabometyx edge in 1L RCC).

Filings in EU, Japan under review

Bristol Myers Squibb noted that this latest approval expands its presence in first-line advanced RCC, which currently includes Opdivo plus the company's anti-CTLA-4 antibody Yervoy (ipilimumab) as a standard of care for intermediate- or poor-risk patients. That combination was approved by the FDA for first-line use in 2018 based on Phase III data from the CheckMate -214 study, where Opdivo plus Yervoy significantly prolonged overall survival versus Sutent in the intermediate- or poor-risk RCC population.

Bristol Myers Squibb and Exelixis' partner Ipsen Pharma, which has exclusive rights to Cabometyx outside the US and Japan, each submitted type II variation applications for Cabometyx plus Opdivo to the European Medicines Agency. The EU regulator has since validated the submissions and started its review process. Meanwhile, Takeda, which is partnered with Exelixis on Cabometyx in Japan, and Ono Pharmaceuticals, which is Bristol Myers Squibb's partner in the country, have also filed the Opdivo/Cabometyx combination for Japanese regulatory approval to treat RCC.

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