Press Release
Press Release
Exelixis’ Cabozantinib Granted Fast Track Designation by FDA For Advanced Renal Cell Carcinoma
Cabozantinib is the subject of METEOR, an ongoing phase 3 pivotal trial
in patients with metastatic RCC who have experienced disease progression
following treatment with at least one VEGFR tyrosine kinase inhibitor.
Patients are randomized 1:1 to receive 60 mg of cabozantinib daily or 10
mg of everolimus daily. The primary endpoint of METEOR is
progression-free survival, and secondary endpoints include overall
survival and objective response rate.
About Metastatic Renal Cell Carcinoma
The American Cancer Society’s 2015 statistics cite kidney cancer as
among the top ten most commonly diagnosed forms of cancer among both men
and women in
Treatments for metastatic RCC had historically been limited to immunotherapy (e.g., interleukin-2 and interferon) until the introduction of targeted therapies into the RCC setting a decade ago. In the second-line setting, which encompasses approximately 11,000 drug-eligible patients in the U.S. and 37,000 globally, four new therapies have been approved in the past five years.5 Despite the availability of several therapeutic options, however, currently approved agents have shown little differentiation in terms of efficacy and have demonstrated only modest PFS benefit in patients refractory to sunitinib, a commonly-used first-line therapy.
About Cabozantinib
Cabozantinib inhibits the activity of tyrosine kinases including MET, VEGFRs and RET. 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.
COMETRIQ® (cabozantinib) is currently approved by the
Important Safety Information, including Boxed WARNINGS
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 patients.
- 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 patients.
- Palmar-Plantar Erythrodysesthesia Syndrome (PPES) 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 with COMETRIQ.
- Avoid administration of COMETRIQ with agents that are strong CYP3A4 inducers or inhibitors.
- COMETRIQ is not recommended for use in patients with moderate or severe hepatic impairment.
- 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.
Please see full U.S. prescribing information, including Boxed WARNINGS,
at www.COMETRIQ.com/downloads/Cometriq_Full_Prescribing_Information.pdf.
Please refer to the full European Summary of Product Characteristics for
full
About
Forward-Looking Statements
This press release contains forward-looking statements, including,
without limitation, statements related to: potential eligibility for
Priority Review of a New Drug Application for cabozantinib for treatment
of patients with metastatic renal cell carcinoma (RCC) who have received
one prior therapy. Words such as “potential,” “eligibility,” “expects,”
and similar expressions are intended to identify forward-looking
statements. These forward-looking statements are based upon Exelixis’
current plans, assumptions, beliefs, expectations, estimates and
projections. Forward-looking statements involve risks and uncertainties.
Exelixis’ actual results and the timing of events could differ
materially from those anticipated in the forward-looking statements as a
result of these risks and uncertainties, which include, without
limitation: risks related to the uncertainties of the regulatory review
and approval processes and Exelixis’ compliance with applicable legal
and regulatory requirements; risks related to the potential failure of
cabozantinib to demonstrate safety and efficacy in clinical testing;
Exelixis’ ability to conduct clinical trials of cabozantinib sufficient
to achieve a positive completion; the availability of data at the
expected times; the uncertain timing and level of expenses associated
with the development of cabozantinib; the clinical, therapeutic and
commercial value of cabozantinib; market competition; changes in
economic and business conditions; and other factors discussed under the
caption “Risk Factors” in Exelixis’ annual report on Form 10-K filed
with the Securities and Exchange Commission (
1http://www.fda.gov/ForPatients/Approvals/Fast/ucm405399.htm
2Cancer Facts & Figures 2015.
3Jonasch et al., BMJ (2014) vol. 349, g4797.
4http://www.cancer.org/cancer/kidneycancer/detailedguide/kidney-cancer-adult-survival-rates
5ACS Cancer Facts and Figures 2015; Heng et al., Ann
Oncol (2012) vol. 23 no. 6; internal data on file; Motzer et al., N Engl
J Med (2007) vol. 356 no. 2; NCIN (
Source:
Exelixis, Inc.
Susan Hubbard, 650-837-8194
Investor
Relations & Corporate Communications
shubbard@exelixis.com