FDA Approves Advanced Renal Cell Carcinoma Treatment

Article

Officials with the FDA recently approved cabozantinib (Cabometyx) for the first-line treatment of patients with advanced renal cell carcinoma (RCC), according to a press release.

Officials with the FDA recently approved cabozantinib (Cabometyx) for the first-line treatment of patients with advanced renal cell carcinoma (RCC), according to a press release.

In 2016, the FDA approved cabozantinib to treat patients with advanced RCC who were previously treated with anti-angiogenic therapy.

The new approval was based on positive findings from the CABOSUN phase 2 clinical trial, which included 157 patients with moderate- and poor-risk untreated RCC. Patients were randomized to receive cabozantinib 60-mg daily or sunitinib 50-mg daily until progression or toxicity.

The mean progression-free survival for patients treated with cabozantinib was 8.6 months compared with 5.3 months for sunitinib-treated patients, according to the FDA.

The most common adverse reactions included diarrhea, fatigue, nausea, decreased appetite, hypertension, palmar-plantar erythrodysesthesia (PPE), weight loss, vomiting, dysgeusia, and stomatitis.

The most severe reactions among patients with RCC were hypertension, diarrhea, hyponatremia, hypophosphatemia, PPE, fatigue, ALT increase, decreased appetite, stomatitis, pain, hypotension, and syncope, according to the release.

The FDA also previously granted approval to cabozantinib for patients with medullary thyroid cancer; however, the drug is marketed as Cometriq for this indication, according to the release. The FDA advised that Cometriq and Cabometyx are different formulations of the drug and cannot be interchanged.

Related Videos
cropped view of man performing chest compression on dummy during cpr training class - Image credit: LIGHTFIELD STUDIOS | stock.adobe.com
Medicine law concept. Judges gavel with pills | Image Credit: Iren Moroz - stock.adobe.com
Image credit: New Africa | stock.adobe.com
biosimilar word or concept represented by wooden letter tiles on a wooden table with glasses and a book | Image Credit: lexiconimages - stock.adobe.com
Image credit: alicja neumiler | stock.adobe.com
Laboratory test tubes and solution with stethoscope background | Image Credit: Shutter2U - stock.adobe.com
Image Credit: Pixel-Shot | stock.adobe.com
Pharmacist holding medicine box and capsule pack in pharmacy drugstore. -- Image credit: I Viewfinder | stock.adobe.com
© 2024 MJH Life Sciences

All rights reserved.