Exelixis, Inc. (EXEL – Analyst Report) announced positive top-line data from the phase II trial, CABOSUN, on Cabometyx in patients suffering from previously untreated advanced renal cell carcinoma (RCC).
Results showed that Cabometyx led to significant improvement in progression-free survival in patients with previously untreated advanced RCC, compared with sunitinib. Consequently, the trial met its primary endpoint.
Safety data from the Cabometyx arm of the study were consistent with those observed in previous studies in patients with advanced RCC.
Final results of the trial will be presented at a medical conference shortly.
We remind investors that Cabometyx (the tablet formulation of cabozantinib) was approved by the FDA in Apr 2016 for the treatment of patients with advanced RCC, who have received prior anti-angiogenic therapy.
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 Exelixis’ partner, Ipsen. The MAA has been granted accelerated assessment by the EMA’s Committee for Medicinal Products for Human Use (CHMP), which translates a review period of 150 days instead of the standard 210 days.
Exelixis also plans to submit results of the CABOSUN trial to regulatory authorities in order to discuss further development of Cabometyx and submission strategy for the treatment of first-line advanced RCC.
As per the American Cancer Society, kidney cancer is one of the top 10 most commonly diagnosed forms of cancer in both men and women in the U.S. Hence, approval of Cabometyx in first-line advanced RCC will boost its growth prospects significantly.
Exelixis currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the healthcare sector include Abbott Laboratories (ABT – Analyst Report) , Johnson & Johnson (JNJ – Analyst Report) and Sanofi (SNY – Analyst Report) . All three stocks carry a Zacks Rank #2 (Buy).