Opdivo-Cabometyx Combo for RCC Given Priority Review Status

Earlier this week, the FDA granted Priority Review status to use a combination of Opdivo-Cabometyx as a treatment for patients with renal cell carcinoma (RCC). According to Healio, Opdivo (nivolumab) and Cabometyx (cabozantinib) might significantly reduce disease progression and improve patient outcomes. Ultimately, the FDA will make its decision on the Opdivo-Cabometyx combination by the end of February 2021.


So what is Priority Review? Before it is approved for marketing and use, each drug must be reviewed by the FDA. According to the Agency:

A Priority Review designation means FDA’s goal is to take action on an application within 6 months (compared to 10 months under standard review). A Priority Review designation will direct overall attention and resources to the evaluation of applications for drugs that, if approved, would be significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications.

Both Opdivo and Cabometyx have proven records for treating RCC. In fact, they even have histories of treating other cancers; for example, Opdivo can be used in conjunction with YERVOY to treat patients with advanced non small cell lung cancer (NSCLC).

Opdivo is a targeted anti-PD-1 antibody. By inhibiting PD-1, Opdivo prompts an anti-tumor immune response, therefore preventing tumor growth. Cabometyx, on the other hand, is a tyrosine kinase inhibitor (TKI) that blocks cell division and prevents tumor growth.

The Priority Review status centered on data from the Phase 3 CheckMate -9ER clinical trial, which evaluated Opdivo-Cabometyx for patients with RCC. 651 patients enrolled. All patients were previously untreated. Approximately half of the patients received the Opdivo-Cabometyx combination, while the other groups received Sutent (sunitinib), another standard treatment option.

Ultimately, the trial found that Opdivo-Cabometyx significantly improved response rates, patient outcomes, and progression-free survival. It was also relatively safe and well-tolerated.

Renal Cell Carcinoma

Smoking, as well as PRC, TFE 3, and VHL gene mutations, have all been linked to kidney cancer. Renal cell carcinoma (RCC) is an easily metastasizing kidney cancer which often spreads to the lungs or other organs. It begins as a tumor in one kidney. However, in rare cases, it can be found in both kidneys. RCC is the most common form of kidney cancer in adults, often affecting males more than females. Generally, patients are diagnosed with RCC between ages 50-70. Symptoms include:

  • Unintended weight loss
  • Abdominal pain
  • Fatigue
  • Bloody or rust-colored urine
  • Testicle enlargement
  • Fever
  • Changes in vision
  • High blood pressure

Learn more about renal cell carcinoma.

Jessica Lynn

Jessica Lynn

Jessica Lynn has an educational background in writing and marketing. She firmly believes in the power of writing in amplifying voices, and looks forward to doing so for the rare disease community.

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