FDA Approves Cabometyx-Opdivo For Metastatic RCC Treatment

After a fast-track designation, the Food and Drug Administration approved the combination of Cabometyx and Opdivo in the firstline setting for patients with advanced or metastatic renal cell carcinoma.

The Food and Drug Administration (FDA) approved today the combination of Cabometyx (cabozantinib) with Opdivo (nivolumab) for patients with advanced renal cell carcinoma. This is a first-line treatment for patients with renal cell carcinoma (RCC) based off the efficacy results in the CHECKMATE-9ER trial.

According to the FDA, the trial showed that there was a statically significant improvement in progression-free survival (PFS), overall survival (OS) and overall response rate (ORR) for patients on the combination of Cabometyx and Opdivo in comparison to those treated with the chemotherapy sunitinib. Median PFS was 16.6 months for patients in the combination arm compared to 8.3 months and confirmed ORR was 55.7% versus 27.1%, and median OS was not reached. Moreover, the PFS results were observed across subgroups of patients with advanced RCC based on their risk factors and PD-L1 tumor expression status.

“As the only combination treatment regimen to double median progression-free survival and objective response rate compared with sunitinib while also significantly improving overall survival, we are excited that Cabometyx in combination with Opdivo is now available for the first-line treatment of patients with advanced kidney cancer,” said Michael M. Morrissey, Ph.D., President and Chief Executive Officer of Exelixis, the manufacture of cabometyx, in a press release. The application of opdivo to this treatment and patient group was granted fast track review by the FDA for the at-risk population of patients with metastatic RCC as it looks to become the standard of care for this group, according to Dr. Toni Choueiri.

The most common side effect observed in the trial was diarrhea, fatigue, hepatotoxicity, palmar-plantar erythrodysaesthesia syndrome, oral mucositis, rash, hypertension, hypothyroidism, musculoskeletal pain, decreased appetite, nausea, distortion of taste, abdominal pain, cough, and upper respiratory tract infection. Discontinuation in the combination arm was 6% of the total patient population with these side effects observed in over 20%.

“This combination of cabometyx and opdivo significantly improved key efficacy measures compared to sunitinib – progression-free survival, overall survival and objective response rate – while showing a low rate of treatment discontinuations due to side effects. The therapeutic benefit demonstrated in CheckMate -9ER and quality of life measures explored emphasize the role of this combination for patients with advanced kidney cancer,” Dr. Choueiri said in the release.

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