FDA approved Cabometyx (cabozantinib) tablets for the treatment of patients with advanced renal cell carcinoma who have received prior anti-angiogenic therapy.
Cabometyx, which was granted Fast Track and Breakthrough Therapy designations by FDA, is the first therapy to demonstrate in a phase III trial for patients with advanced RCC, robust and clinically meaningful improvements in overall survival, progression-free survival and objective response rate, according to the drug’s sponsor, Exelixis Inc.
“The efficacy profile demonstrated by Cabometyx in the METEOR trial, now complemented by the overall survival benefit, is highly compelling,” said Toni Choueiri, clinical director at the Lank Center for Genitourinary Oncology at Dana-Farber Cancer Institute. “Cabometyx is distinct from other approved treatment options, as it targets multiple tyrosine kinases involved in the development of RCC, including MET, AXL and three VEGF receptors.”
The approval of Cabometyx is based on results of the phase III METEOR trial, which met its primary endpoint of improving progression-free survival. Compared with everolimus, a standard of care therapy for second-line RCC, CABOMETYX was associated with a 42 percent reduction in the rate of disease progression or death. Median progression-free survival for cabozantinib was 7.4 months versus 3.8 months for everolimus (HR=0.58, 95% CI 0.45-0.74, P<0.0001). Cabometyx also significantly improved the objective response rate compared with everolimus. These data were presented at the European Cancer Congress in September 2015 and published in The New England Journal of Medicine.
FDA granted Orphan Drug Designation to VAL-083 in the treatment of ovarian cancer.
The investigational drug candidate, developed by DelMar Pharmaceuticals Inc., previously received an orphan designation for glioma and medulloblastoma in the United States and glioma in Europe.
In more than 40 phase I and II clinical studies sponsored by NCI, VAL-083 demonstrated clinical activity against a range of cancers including lung, brain, cervical, ovarian tumors and leukemia both as a single-agent and in combination with other treatments.
“We are pleased to receive the designation, which is timely in light of new data presented this week with supporting the potential for VAL-083 in the treatment of ovarian cancer,” said Jeffrey Bacha, chairman and CEO of DelMar Pharmaceuticals. “This announcement is representative of the progress we’ve made in developing VAL-083 which we believe positions the therapy as a viable treatment option for ovarian cancer patients.”
DelMar’s collaborators from MD Anderson Cancer Center presented preclinical data at the annual meeting of the American Association for Cancer Research, demonstrating that VAL-083 appears to have a distinct mode of action from platinum-based chemotherapies widely used in the treatment of ovarian cancer. In these studies, VAL-083 demonstrated an ability to circumvent cisplatin-resistance in all ovarian cell lines tested.