|[January 24, 2013]
Exelixis Announces COMETRIQ™ (cabozantinib) Is Now Available in the U.S.
SOUTH SAN FRANCISCO, Calif. --(Business Wire)--
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
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
prescibing 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
Serious and sometimes fatal gastrointestinal perforations and
fistulas occur in COMETRIQ-treated patients.
Severe and sometimes fatal hemorrhage occurs in COMETRIQ-treated
COMETRIQ treatment results in an increase in thrombotic events, such
as heart attacks.
Wound complications have been reported with COMETRIQ.
COMETRIQ treatment results in an increase in hypertension.
Osteonecrosis of the jaw has been observed in COMETRIQ-treated
Palmar-Plantar Erythrodysesthesia (PPE) Syndrome occurs in patients
treated with COMETRIQ.
The kidneys can be adversely affected by COMETRIQ. Proteinuria and
nephrotic syndrome have been reported in patients receiving COMETRIQ.
Reversible Posterior Leukoencephalopathy Syndrome has been observed
COMETRIQ can cause fetal harm when administered to a pregnant woman.
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
For full prescribing information, including Boxed Warning, please visit www.exelixis.com
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.
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