Exelixis, Inc. (NASDAQ: EXEL) today announced the commercial availability of COMETRIQ® (cabozantinib) for the treatment of patients with progressive, metastatic medullary thyroid cancer (MTC). The U.S. Food and Drug Administration (FDA) approved COMETRIQ on November 29, 2012. COMETRIQ is being distributed exclusively through Diplomat Specialty Pharmacy in the U.S.
To help ensure patients have access to COMETRIQ, Exelixis has implemented a comprehensive reimbursement and support program – Exelixis Access Services. The program offers several key components, including co-pay assistance for qualified, commercially-insured patients; medication at no cost for uninsured patients that meet certain financial criteria; and, contributions to independent co-pay assistance charities to help patients who do not qualify for the co-pay assistance program. Exelixis Access Services also offers comprehensive reimbursement support services, such as prior authorization support, benefits investigation and, if needed, appeals support. Information about Exelixis Access Services is available at www.COMETRIQ.com or 1-855-253-3273.
COMETRIQ (cabozantinib) inhibits the activity of tyrosine kinases including RET, MET and VEGFR2. These receptor tyrosine kinases are involved in both normal cellular function and in pathologic processes such as oncogenesis, metastasis, tumor angiogenesis, and maintenance of the tumor microenvironment.
Exelixis received approval by the FDA to market COMETRIQ in the United States for the treatment of progressive, metastatic MTC in November 2012. Please see important safety information below, and the full prescribing information, including Boxed Warning, for COMETRIQ at www.exelixis.com or www.COMETRIQ.com.
COMETRIQ™ Important Safety Information, including Boxed Warning
WARNING: PERFORATIONS AND FISTULAS, and HEMORRHAGE
Adverse Reactions – The most commonly reported adverse drug reactions (=25%) are diarrhea, stomatitis, palmar-plantar erythrodysesthesia syndrome (PPES), decreased weight, decreased appetite, nausea, fatigue, oral pain, hair color changes, dysgeusia, hypertension, abdominal pain, and constipation. The most common laboratory abnormalities (=25%) are increased AST, increased ALT, lymphopenia, increased alkaline phosphatase, hypocalcemia, neutropenia, thrombocytopenia, hypophosphatemia, and hyperbilirubinemia.
Drug Interactions – COMETRIQ is a CYP3A4 substrate. Co-administration of strong CYP3A4 inhibitors can increase cabozantinib exposure. Chronic co-administration of strong CYP3A4 inducers can reduce cabozantinib exposure.
Exelixis, Inc. is a biotechnology company committed to developing small molecule therapies for the treatment of cancer. Exelixis is focusing its proprietary resources and development efforts exclusively on its lead product, COMETRIQ. Exelixis has also established a portfolio of other novel compounds that it believes have the potential to address serious unmet medical needs, many of which are being advanced by partners as part of collaborations. For more information, please visit the company's web site at www.exelixis.com.Business Wire
Last updated on: 24/01/2013