Exelixis' Cabometyx Gets FDA Nod For First-Line Kidney Cancer

Exelixis, Inc. (NASDAQ:EXEL) recently announced FDA approval for label expansion of its lead drug Cabometyx for the treatment of previously untreated advanced renal cell carcinoma (RCC).

The approval came on the back of positive results from the randomized phase II, trial CABOSUN on first line kidney cancer. The results demonstrated statistically significant and clinically meaningful improvement in progression-free survival (PFS) versus Pfizer Inc.’s (NYSE:PFE) Sutent.

We remind investors that the company received a significant boost in April 2016 when the FDA approved the tablet formulation of cabozantinib (distinct from the capsule form) under the brand name Cabometyx for the treatment of RCC in patients who have already received anti-angiogenic therapy. Cabometyx was also approved in the EU in September 2016 for the treatment of advanced RCC in adults who had earlier received vascular endothelial growth factor (VEGF)-targeted therapy.

Cabometyx raked in strong sales in the first nine months of 2017, reflecting the rising demand for the drug. New patient market share in the second-line plus setting rose to 38%.

Hence, a label expansion of the drug for first-line treatment of kidney cancer will increase the target market and boost sales.

Exelixis’ share price has increased 78.9% year to date compared with the industry’s gain of 4.2%.

Meanwhile, the CELESTIAL study for advanced hepatocellular carcinoma (HCC) is in progress and the top-line results are expected shortly. The company obtained orphan drug designation for the same in the United States. HCC is the most common form of primary liver cancer, accounting for more than 90% of cases in the United States. In October, Exelixis announced that the CELESTIAL trial met its primary endpoint of overall survival (OS) with cabozantinib providing statistically significant and clinically meaningful improvement in OS compared to placebo in patients with advanced HCC. The independent data monitoring committee for the study recommended that the trial to be stopped for efficacy following review of the second planned interim analysis. Exelixis plans to submit an sNDA to the FDA in the first quarter of 2018.

Exelixis has also inked agreements with Bristol-Myers Squibb Company (NYSE:BMY) and Roche Holding (SIX:ROG) AG (OTC:RHHBY) to develop cabozantinib in combination with immunotherapy agents.

Zacks Rank

Exelixis carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

5 Medical Stocks to Buy Now

Zacks names 5 companies poised to ride a medical breakthrough that is targeting cures for leukemia, AIDS, muscular dystrophy, hemophilia, and other conditions.

New products in this field are already generating substantial revenue and even more wondrous treatments are in the pipeline. Early investors could realize exceptional profits.

Click here to see the 5 stocks >>