December 19, 2017 — South San Francisco, CA — (Business Wire)
Exelixis, Inc. (NASDAQ: EXEL) announced that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for Cabozantinib tablets for the treatment of patients with advanced renal cell carcinoma (RCC). RCC is the most common type of kidney cancer in adults. The FDA’s Priority Review and approval of Cabozantinib were based on results from the randomized Phase 2 CABOSUN trial in patients with previously untreated RCC; this trial demonstrated that, compared to the current standard of care, sunitinib, Cabozantinib provided a statistically significant and clinically meaningful improvement in progression-free survival (PFS). This label expansion follows Cabozantinib’s initial FDA approval in April 2016, when the drug was approved for the treatment of patients with advanced RCC who had previously received anti-angiogenic therapy. Dr. Michael M. Morrissey, President and CEO of Exelixis, stated: "Today’s approval of Cabozantinib represents a true victory for patients in the U.S. with advanced renal cell carcinoma, who now have a new first-line treatment option. We are delighted by this expanded indication and are ready to bring Cabozantinib—starting today—to all eligible patients who may benefit from this important therapeutic option. I would like to extend my heartfelt thanks to the patients and clinicians who participated in the CABOSUN trial, to the Alliance and NCI-CTEP, and to our dedicated clinical, medical, and regulatory teams for their tireless efforts in making this possible. We also thank the FDA review team for their expeditious review of our application."
Dr. Toni Choueiri, Director of the Lank Center for Genitourinary Oncology at Dana-Farber Cancer Institute, commented: "The CABOSUN trial enrolled patients with previously untreated advanced kidney cancer—including those with a known poor prognosis, such as patients with intermediate- or poor-risk prognostic factors, as well as those with bone metastases or multiple metastatic sites. Clinicians have already gained experience using Cabozantinib in the second-line setting for advanced renal cell carcinoma; the ability to now offer Cabozantinib as a treatment option for patients with previously untreated advanced renal cell carcinoma represents a much-needed advancement."
The expanded approval of Cabozantinib is based on the results of the Phase 2 CABOSUN trial, which met its primary endpoint of improving progression-free survival (PFS). Based on an analysis of the data by an Independent Radiology Review Committee (IRC), Cabozantinib demonstrated a clinically meaningful and statistically significant 52% reduction in the risk of disease progression or death (Hazard Ratio [HR] 0.48; 95% Confidence Interval [CI] 0.31–0.74; two-sided P=0.0008). The median progression-free survival in the Cabozantinib arm was 8.6 months, compared to 5.3 months in the Sunitinib arm—representing an improvement of 3.3 months (62%).
Michael J. Morris, MD, a medical oncologist at Memorial Sloan Kettering Cancer Center and Chair of the Alliance Genitourinary (GU) Committee, stated: "We at the Alliance for Clinical Trials in Oncology are very pleased that the CABOSUN study supports the potential approval of Cabozantinib as a first-line treatment option for all patients with advanced renal cell carcinoma. This trial exemplifies how research funded by the National Cancer Institute (NCI) can efficiently and rapidly enroll patients, generating results that are highly relevant to the field."
