The FDA Approval of Exelixis Drug Cabometyx™ Is Indeed Great News


The FDA approved Exelixis’ (EXEL) drug Cabometyx™ (cabozantinib) tablets for advanced renal cell carcinoma (RCC) patients who have received prior anti-angiogenic therapy.

RCC is the most common form of kidney cancer in adults.

Cabometrix is the first drug to demonstrate robust and clinically meaningful improvements in a phase 3 trial in patients with advanced RCC. The drug satisfied all key efficacy parameters — overall survival, progression-free survival and objective response rate.

Reaching the market in around two weeks, Cabometyx will bring back hope to patients who lost it after the failure of their previous treatments. As successful as it has demonstrated in late phase trial, Cabometix will extend overall survival of renal cell carcinoma patients. Indeed, the drug promises those patients to live longer, while delaying the progression of their cancer.

Toni Choueiri, MD, Clinical Director, Lank Center for Genitourinary Oncology, Dana-Farber Cancer Institute said, “The efficacy demonstrated by Cabometyx in the METEOR trial, now complemented by the overall survival benefit, is highly compelling. Cabometyx is distinct from other approved treatment options, as it targets multiple tyrosine kinases involved in the development of RCC, including MET, AXL and three VEGF receptors. At the same time, physicians are very familiar with this class of drug and how to use dose adjustments to balance safety and efficacy. The approval of CABOMETYX is wonderful news for physicians who are looking for a new option for their previously treated patients with advanced kidney cancer.”

The approval is based on results of the phase 3 METEOR trial, which met its primary endpoint of improving progression-free survival. Compared with everolimus, a standard of care therapy for second-line RCC. Cabometyx was associated with a 42 percent reduction in the rate of disease progression or death. Median progression-free survival for cabozantinib was 7.4 months versus 3.8 months for everolimus. The drug has shown to significantly improve the objective response rate compared with everolimus.

In February 2016, results from the METEOR trial demonstrate that Cabometyx reached statistical significance and clinically meaningful increase in overall survival with 34 percent reduction in the rate of death compared with everolimus. Median overall survival was 21.4 months for patients receiving cabometyx versus 16.5 months for those receiving everolimus.

To learn about Important Safety Information and full U.S. prescribing information click on the following link:

Cabometyx targets include MET, AXL and VEGFR-1, -2 and -3. In preclinical models, the drug has been confirmed to inhibit the activity of these receptors, which are involved in normal cellular function and in tumor angiogenesis, invasiveness, metastasis and drug resistance.

CABOMETYX, the tablet formulation of cabozantinib, will be available in 20 mg, 40 mg or 60 mg doses. The recommended dose is 60 mg orally, once daily.

 Prohost Observations

Again, we congratulate our readers who did not give up to negative bloggers who tried all means to let them sell EXEL for reasons that are simply unreasonable. With regard to future marketing in Europe, Exelixis has already found a partner, Ipsen, and signed a collaborative agreement with it for marketing the drug in the European Union. Claiming that the firm will not be able to market the drug in the U.S. alone does not really make sense. The firm is already marketing the drug successfully for thyroid cancer at the hands of a marketing team that is very well trained. Also, oncologists have already become familiar with the drug and its use towards having the utmost efficacy with the lowest adverse events.

Regarding the competition, we believe that Cabometix’ mode of action and its three targets makes it a great selection for combination treatment with approved, or experimental immunotherapy drugs. In addition, the drug met all endpoints of the trial, including the most important, i.e., overall survival.

With this approval, Exelixis is currently having on the market two drugs treating three cancers.

Cabozantinib is sold as:

Cometric for progressive, metastatic medullary thyroid cancer (MTC) and as Cabometyxfor renal cell carcinoma.

Cobimetinib –  a selective inhibitor of MEK being developed by Genentech (a member of the Roche Group) under a collaboration agreement with Exelixis. The drug is approved forunresectable or metastatic melanoma with a BRAF V600E or V600K mutation, in combination with vemurafenib. In the United States, cobimetinib is marketed asCottelic™. For

Both drugs’ targets make us believe that they will be receiving further approvals for more cancers. We reiterate that there is good possibility that cabozantinib will be approved in combination with immunotherapy drugs and other drugs for the sake of improving the outcome of treatments of different cancers.

The approval was expected, yet, it is still great news.

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