Exelixis Wins Big With FDA Approval

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Exelixis Inc. (NASDAQ: EXEL) saw its shares make a handy gain on Wednesday after the company was tapped by the U.S. Food and Drug Administration (FDA). Specifically, the FDA has approved Cabometyx (cabozantinib) tablets for the expanded indication of patients with advanced renal cell carcinoma (RCC), which is the most common form of kidney cancer in adults.

The FDA’s priority review and approval of Cabometyx was based on results from the Phase 2 Cabosun trial in patients with previously untreated RCC, which demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) versus sunitinib, a current standard of care.

The median PFS for Cabometyx was 8.6 months, versus 5.3 months for sunitinib, reflecting a 3.3 month, or 62%, improvement.

This label expansion follows the initial FDA approval of Cabometyx in April 2016 for the treatment of patients with advanced RCC who have previously received anti-angiogenic therapy.

Michael M. Morrissey, Ph.D., president and CEO of Exelixis, commented:

Today’s approval of CABOMETYX is a true win for patients in the U.S. with advanced renal cell carcinoma who now have a new first-line treatment option. We are very pleased with the expanded indication and are prepared to bring CABOMETYX to all eligible patients who may benefit from this important treatment option starting today. I would like to sincerely thank the patients and clinicians who participated in the CABOSUN trial, the Alliance and NCI-CTEP, as well as our dedicated clinical, medical and regulatory teams for their tireless efforts to this end. We would also like to acknowledge the review team at FDA for their expeditious review of our application.

Shares of Exelixis traded up over 4% at $27.89 on Wednesday, with a consensus analyst price target of $33.14 and a 52-week range of $14.22 to $32.50.