A SUPPLEMENT TO VOL. 34 SUPPL. 7
Deepak Kilari, MD
Assistant Professor of Medicine
Medical College of Wisconsin
Clement J. Zablocki Veterans Affairs Medical Center
Renal cell carcinoma (RCC) is the most common form of
kidney cancer.1 In 2014, there were more than 483,000
cases of kidney cancer in the United States.2 In 2017,
there are expected to be more than 63,000 new cases of
kidney cancer in the United States with more than 14,000
deaths attributed to the disease.2 RCC is more common
in men than women and is most frequently diagnosed
in patients aged 65 to 74 years.2 At diagnosis, about
one-third of patients have metastatic disease, and close
to 1 in 3 patients with localized disease will ultimately
In a review of Veterans Health Administration (VHA)
data from 2015, there were 20,943 cases of malignant
neoplasm of the kidney (ICD9 Code 189.0) in the
outpatient setting.3 In the same year, the VHA reported
3609 cases of malignant neoplasm of the kidney in the
inpatient setting.3 Kidney cancers account for 3.3% of all
cancers among veterans.4
This supplement will review publications, in both
The Lancet Oncology and New England Journal
of Medicine, of the metastatic RCC phase 3 study
evaluating cabozantinib versus everolimus (METEOR)
that supported the US Food and Drug Administration
(FDA) approval of CABOMETYX™ (cabozantinib) tablets
in advanced RCC after prior anti-angiogenic therapy.
From time to time, this supplement will point out
differences between the content of the literature and the
approved Prescribing Information for CABOMETYX. It’s
important that readers are aware of these distinctions.
CABOMETYX™ (cabozantinib) is indicated for the treatment of advanced renal cell carcinoma (RCC) in patients who have
received prior anti-angiogenic therapy.
IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS
• Severe Hemorrhage occurred with CABOMET YXTM. Grade ≥3 hemorrhagic events occurred in 2.1% of CABOME TYX
patients vs 1.6% of everolimus patients. Fatal hemorrhages also occurred in the cabozantinib clinical program. Do
not administer CABOMETYX to patients that have or are at risk for severe hemorrhage.
• Gastrointestinal (GI) Perforations and Fistulas were reported. Fistulas were reported in 1.2% (with 0.6% anal fistula)
of CABOMETYX patients vs 0% of everolimus patients. GI perforations were reported in 0.9% of CABOMETYX
patients vs 0.6% of everolimus patients. Fatal perforations occurred in the cabozantinib clinical program. Monitor
patients for symptoms. Discontinue CABOMETYX in patients who experience a fistula that cannot be appropriately
managed or a GI perforation.
Please see Important Safety Information on pages 1S to 10S. Please see Brief Summary of the
full Prescribing Information on pages 11S–12S or view the full Prescribing Information here.
This supplement is sponsored by Exelixis, Inc.
Advanced Renal Cell Carcinoma:
A Treatment Option for Patients Who Have
Received Prior Anti-Angiogenic Therapy
Dr. Kilari is a paid consultant for Exelixis, Inc. This content was developed in conjunction with Exelixis, Inc., and Dr. Kilari.
Dr. Kilari received a fee for participating in this program.