Good News about CABO
The FDA has determined that Exelixis’ (EXEL) cabozantinib New Drug Application (NDA) for advanced renal cell carcinoma (RCC) to be sufficiently complete to permit a substantive review.
The NDA will be considered officially filed 60 days from the date of the completion of the submission, or February 20, 2016. The FDA granted Priority Review to the filing and assigned a Prescription Drug User Fee Act action date of June 22, 2016.
Exelixis is, indeed, one step closer to marketing cabozantinib as important therapeutic option for advanced renal cell carcinoma. The firm is readying itself for a potential launch by April 1stof this year.”
The FDA had granted cabozantinib Breakthrough Therapy designation (August 2015) and Fast Track designation (April 2015) for the compound’s proposed RCC indication.
The NDA is based on the results of a Phase 3 METEOR pivotal trial comparing cabozantinib to everolimus in patients with advanced RCC who experienced disease progression following treatment with a VEGF receptor tyrosine kinase inhibitor.
In July 2015, Exelixis announced the trial had met its primary endpoint of improving progression-free survival; compared with everolimus, cabozantinib was associated with a 42% reduction in the rate of disease progression or death.
The same data were presented at the European Cancer Congress in September 2015 and concurrently published in The New England Journal of Medicine.
Everybody believed in this good news but negative Wall Street bloggers, shorting investors and their followers.
Regarding Europe, on January 11, 2016, Exelixis announced the submission of a Marketing Authorization Application (MAA) for cabozantinib as a treatment for patients with advanced RCC who have received one prior therapy to the European Medicines Agency (EMA). The EMA’s Committee for Medicinal Products for Human Use (CHMP) previously granted accelerated assessment to cabozantinib for advanced RCC.
As a result, the company’s MAA will be eligible for a 150-day review, versus the standard 210 days (excluding clock stops when information is requested by CHMP).
Cabozantinib is marketed in capsule form under the brand name COMETRIQ® in the United States for progressive, metastatic medullary thyroid cancer (MTC), and in Europe for adult patients with progressive, unresectable locally advanced or metastatic MTC.
Is this news great?
For everybody other than Wall Street negative dominating investors and advisors.