Exelixis, Inc. (NASDAQ:EXEL) Submits to the FDA Supplemental New Drug Application for Cabozantinib Plus Nivolumab as Treatment for RCC

Exelixis, Inc. (NASDAQ:EXEL) has completed the first regulatory submission, a supplemental new drug application (sNDA) for CABOMETYX® (cabozantinib). This incorporates nivolumab (Opdivo) and is a potential treatment for treating advanced renal cell carcinoma (RCC). Results witnessed in the pivotal, phase 3 CheckMate-9ER trial evaluating cabozantinib are what triggered the new application. Additionally, the multi-national phase 3 trial had earlier met its primary endpoint of improving progression-free survival (PFS) significantly.

Data from the phase 3 pivotal CheckMate-9ER clinical trial also support the NDA. The trial randomized patients 1:1 and key secondary endpoints observed included overall survival (OS) and objective response rate (ORR). The preliminary assessment had demonstrated a favorable safety profile even though there were few treatment discontinuations due to adverse events.

The approval of [cabozantinib] and [nivolumab] will be an Important Milestone

Exelixis has the right to commercialize cabozantinib in the United States. The CABOMETYX tablets have an approval in the European Union and other exclusive regionals across the globe. They are primarily for use in patients who have previously been treated with sorafenib.

However, through a license agreement, Takeda Pharmaceutical Company Limited can also use cabozantinib in Japan for further clinical development or future indications.

There is high anticipation of approval of the combination of CABOMETYX and Opdivo. Chief Medical Officer of Exelixis, Gisela Schwab, says that this would give RCC patients additional therapeutic options an extension of their survival. It will be a new first-line treatment regimen for them.

Exelixis’ partnership with leading pharmaceutical companies

Exelixis has confirmed that it has been working with Bristol Myers Squibb and Ono Pharmaceuticals and that it was just a co-founder of the study. It will continue working with the duo and the FDA as it pursues the regulatory review process.

Collaboration with leading pharmaceutical companies has been the key strategy for the company’s growth. This is because it is committed to investing prudently in the business to maximize its pipeline’s potential. Exelixis has also invested heavily in research and development, and over the decades, it has gained substantial experience in different drug development processes.