Stage 4 Kidney Cancer: Cabozantinib Receives FDA Approval for 1st-Line Treatment

On 19 December 2017, the United States Food and Drug Administration FDA, approved Cabometyx, containing the active ingredient cabozantinib, for first-line treatment of stage 4 renal cell cancer.

Cabozantinib was approved in 2016 for patients who had previously received antiangiogenic therapy, meaning in the second-line setting.

Previously FDA-approved first-line treatments for advanced (stage 4) kidney cancer were interferon+bevacizumab, pazopanib (Votrient) and sunitinib (Sutent).

Renal cell carcinoma , also known as kidney cell cancer, is the most common type of kidney cancer, accounting for %90 of cancers arising in the kidney.

This approval was based on data from CABOSUN, an open-label, randomized, multicenter study involving previously untreated kidney cancer patients at intermediate or poor risk: 157 patients in a phase 2 trial (NCT01835158). Patients received daily oral Cabometyx (79 people), 60 mg, or oral sunitinib (78 people), 50 mg, until disease progression or unacceptable toxicity (side effects).

In patients taking Cabometyx, the period for which treatment kept the disease under control (progression-free survival) was 8.6 months, compared with 5.3 months in those receiving sunitinib. Overall, the risk of disease progression was found to be % 52 lower in those receiving cabozantinib. The most commonly reported side effects (≥% 25) in the Cabometyx clinical program were diarrhea, fatigue, nausea, decreased appetite, hypertension, palmar-plantar erythrodysesthesia (allergy/rash on the hands and feet), weight loss, vomiting and mouth sores. Hypertension, diarrhea, hyponatremia (low sodium), hypophosphatemia (low phosphate), fatigue, increased ALT, decreased appetite, stomatitis, pain, hypotension and syncope (fainting) were the most common grade 3. - 4. side effects (at a rate of ≥% 5).

The recommended Cabometyx dose is 60 mg orally once daily.

Cabozantinib is also approved for treating medullary thyroid cancer and is marketed under the trade name Cometriq. Cometriq and Cabometyx have different formulations and are not interchangeable.