Exelixis, Inc. (NASDAQ:EXEL) , along with its partner Ipsen, announced positive data from subgroup analyses of the METEOR trial on Cabometyx (tablet formulation of cabozantinib) at the 2016 American Society of Clinical Oncology (ASCO) Annual Meeting.
The trial compared Cabometyx with Afinitor in patients suffering from advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy.
Data from the studies showed that treatment with Cabometyx improved progression-free survival (PFS) and overall survival (OS) in patients who had bone metastases at baseline.
Trial data also showed that the benefits of Cabometyx in PFS and OS were independent of the presence of bone metastases, prior anti-PD-1/PD-L1 therapy, and the type of prior vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI) therapy. They were, in fact, consistent regardless of prior treatment, location and extent of tumor metastases.
Shares of the company gained 11.2% on the news.
We remind investors that Cabometyx was approved by the FDA in Apr 2016 for the treatment of patients with advanced RCC who have received prior anti-angiogenic therapy.
The FDA approval of Cabometyx for RCC is a major boost for the company and will drive the top line in the forthcoming quarters.
Meanwhile, the European Medicines Agency (EMA) has accepted a Marketing Authorisation Application (MAA) for Cabometyx for review in the same indication. Upon a potential approval, the drug would be marketed in the EU by Ipsen. The MAA was granted accelerated assessment by the EMA’s Committee for Medicinal Products for Human Use (CHMP), which translates to a review period of 150 days instead of the standard review period of 210 days.
Cometriq, the capsule form of cabozantinib is approved for the treatment of progressive, metastatic medullary thyroid cancer.
Exelixis currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Pfizer Inc. (NYSE:PFE) , Johnson & Johnson (NYSE:JNJ) and Abbott Laboratories (NYSE:ABT) . While Pfizer sports a Zacks Rank #1 (Strong Buy), Johnson & Johnson and Abbott Labs carry a Zacks Rank #2 (Buy).
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