Exelixis Drug Recieves Breakthrough Therapy Designation
The U.S. Food & Drug Administration (FDA) has announced today that it has granted a Breakthrough Therapy Designation for the pharmaceutical giants Exelixis (NASDAQ: EXEL), for the drug Cabozantinib. Cabozantinib, which is currently marketed in capsule form under the brand name Cometriq, is a drug developed by Exelixis that can help with treatment for patients with advanced renal cell carcinoma (RCC).
Drugs that receive Breakthrough Therapy Designation may benefit from involvement of FDA senior managers in the review process, potential rolling submission and/or Priority Review of a sponsor’s New Drug Application (NDA), and other benefits.
Michael M. Morrissey, Ph.D., president and chief executive officer of Exelixis said “Receiving Breakthrough Therapy Designation is an important regulatory achievement for cabozantinib in renal cell carcinoma,”. He continued “Following the positive top-line results announced in July and a productive dialogue with the FDA, Exelixis believes we can expedite our regulatory timelines and complete the cabozantinib NDA submission in advanced RCC prior to the end of 2015. We look forward to working closely with the FDA during the submission and review process, keeping in mind our ultimate goal of bringing a new therapeutic option to the renal cell carcinoma community as soon as possible.”
In the US the treatment of progressive, metastatic medullary thyroid cancer (MTC) has approved the drug, while conditional approval has been granted in the EU for the treatment of adult patients with progressive, unresectable locally advanced or metastatic MTC. Moreover, the impressive drug is being evaluated for its treatment on different types of cancer, for example hepatocellular carcinoma.