In December 2005, the FDA approved Nexavar® (sorafenib) tablets for the treatment of patients with advanced kidney cancer. The companies also announced the initiation of the Resources for Expert Assistance and Care Helpline (REACH®), which is available to answer questions about Nexavar treatment, reimbursement, and patient support. For more information, healthcare providers and patients may contact the REACH program at 1.866.NEXAVAR (1.866.639.2827) (view press release).
Nexavar's approval in the U.S. followed a report at the annual meeting of the American Society of Clinical Oncology (ASCO) in May 2005 that Nexavar was generally well tolerated and significantly delayed disease progression in an ongoing Phase 3 clinical trial in patients with advanced kidney cancer. As assessed by independent radiologic review, progression-free survival (PFS) was doubled to a median value of 24 weeks (167 days) in patients receiving Nexavar, compared to 12 weeks (84 days) for patients receiving placebo (view press release).
In July 2006, the European Commission granted marketing authorization to Nexavar for the treatment of patients with advanced renal cell carcinoma who have failed prior interferon-alpha or interleukin-2 based therapy or are considered unsuitable for such therapy (view press release).