Cabometyx and OPDIVO Approved in Japan for RCC

According to a news release from August 25, 2021, Cabometyx (cabozantinib), in conjunction with OPDIVO (nivolumab), has been approved in Japan for patients with unresectable or metastatic renal cell carcinoma (RCC). Altogether, the approval hinged on data from the Phase 3 CheckMate -9ER clinical trial, which compared the therapy to sunitinib treatment. During the trial, researchers discovered that the combination of Cabometyx and OPDIVO significantly improved both overall and progression-free survival rates, as well as objective response rate, as compared to sunitinib.

Cabometyx

So what exactly is Cabometyx? According to Drugs.com, Cabometyx is:

a kinase inhibitor, a type of enzyme inhibitor that blocks the action of certain protein kinases.

Outside of treating RCC, Cabometyx may also be used to treat patients with hepatocellular carcinoma, a type of liver cancer. The drug’s most recent approval depended on data from the Phase 3 CheckMate -9ER clinical trial, which evaluated Cabometyx and Opdivo in patients with treatment-naive advanced or metastatic RCC. Altogether, 651 patients enrolled. During the trial, patients received either 40mg Cabometyx, as well as Opdivo, or sunitinib. The drug showed significant improvement in survival rates and patient outcomes. Now that it is approved, the treatment can help patients in Japan and fulfill an unmet need.

While Cabometyx is relatively safe and well-tolerated, there are possible side effects. These include:

  • Diarrhea or constipation
  • Unintended weight loss
  • High blood pressure
  • Fatigue
  • Appetite loss
  • Proteinuria (excess protein in the urine)
  • Nausea and vomiting
  • Rash
  • Stomatitis (inflamed and sore mouth)

Serious and life-threatening reactions may also occur. If taking Cabometyx, be looking out for the following, and speak to your doctor about canceling treatment if these occur:

  • Hemorrhage
  • Venous or arterial thromboembolisms
  • Fistulas and GI tract perforations
  • Adrenal insufficiency
  • Liver toxicity
  • Hypertensive crisis
  • Osteonecrosis of the jaw
  • Reversible posterior leukoencephalopathy syndrome, which may manifest as seizures or visual disturbances

Renal Cell Carcinoma (RCC)

Doctors are not sure of the exact cause of renal cell carcinoma (RCC), a malignant and quick-spreading kidney cancer. However, there are several risk factors: smoking cigarettes, being male, age (50-70), a history of kidney problems, or PRCTFE 3, and VHL gene mutations. Typically, RCC first manifests as a tumor on one kidney, though it may appear on both. Symptoms include:

  • Unintended weight loss
  • Hematuria (blood in the urine)
  • Abdominal pain
  • Enlarged testicle(s)
  • Fever
  • High blood pressure
  • Fatigue