FDA expanded the indication on cabozantinib (Cabometyx, Exelixis) to treat patients with advanced renal cell carcinoma (RCC).
Cabometyx was initially approved in April 2016, to treat patients with advanced RCC who had previously received anti-angiogenic therapy.
The new indication, which received FDA priority review, was based on results from the randomized phase 2 CABOSUN trial in patients with previously untreated RCC, which demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) versus sunitinib (Sutent, Pfizer), a current standard of care.
FDA’s approval of Cabometyx is “a true win for patients in the U.S. with advanced renal cell carcinoma who now have a new first-line treatment option,” said Michael M. Morrissey, PhD, president and CEO of Exelixis, in a statement.
“Physicians are already experienced in using Cabometyx in the second-line advanced RCC setting, and it is a much-needed advance to also now have Cabometyx as an option for their patients with previously untreated advanced RCC,” said Toni Choueiri, MD, director of the Lank Center for Genitourinary Oncology, Dana-Farber Cancer Institute.
The CABOSUN trial enrolled treatment-naïve patients with advanced kidney cancer, including those who are known to fare poorly, such as patients with intermediate- or poor-prognostic factors and those with bone metastases or multiple sites of metastatic disease, Choueiri added.