Exelixis, Inc.’s EXEL oncology drug, Cometriq (cabozantinib), received fast-track status from the FDA for the treatment of patients with advanced renal cell carcinoma (RCC) who have received one prior therapy.
The FDA grants fast track designation to those candidates that are being developed for the treatment of serious conditions with unmet medical need. The overall goal of the process is to get new drugs to patients faster.
Cometriq is already approved in the U.S. for the treatment of progressive, metastatic medullary thyroid cancer (MTC). Additionally, it has been granted conditional approval in the EU for the treatment of adult patients with progressive, unresectable locally advanced or metastatic MTC. The company has a distribution and commercialization agreement with Swedish Orphan Biovitrum AB (Sobi) for the MTC indication of Cometriq in the EU, Switzerland, Norway, Russia and Turkey and potentially other countries.
We note that recently Celldex Therapeutics, Inc. CLDX entered into a clinical trial collaboration with Roche RHHBY to evaluate Celldex’s varlilumab plus Roche’s MPDL3280A for the treatment of RCC.
Cometriq is currently being evaluated in a phase III pivotal study (METEOR) in patients with metastatic RCC who been treated with at least one VEGFR tyrosine kinase inhibitor. Top-line results from this study are expected in the second quarter of 2015. The company is also evaluating Cometriq in another phase III study (CELESTIAL) for the treatment of second-line hepatocellular carcinoma.
Apart from these two studies, Cometriq is being evaluated in other studies for a wide range of cancers including second- or later-line persistent or recurrent ovarian cancer (phase II) and second or third-line EGFR wild-type non-small cell lung cancer (phase II).
Meanwhile, Exelixis has several pipeline and regulatory updates lined up this year. The company expects the FDA to deliver a response by Aug 11 on the approval status of cobimetinib for use in combination with Zelboraf (vemurafenib) for the treatment of BRAF V600 mutation-positive advanced melanoma. We note that the company has an agreement with Genentech, a subsidiary of Roche, for cobimetinib.
The company also expects data from the Cometriq phase II studies in the first half of 2015.
We are encouraged by the company’s effort to expand the label of its lead drug, Cometriq, and expect investor focus to remain on further company updates.
Exelixis is a Zacks Rank #2 (Buy) stock. Other favorably-placed stocks in the health care sector include Cambrex Corp. CBM, sporting a Zacks Rank #1 (Strong Buy).
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