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The first and only TKI to surpass the efficacy of sunitinib in first-line advanced RCC-expanded indication and new data1*
CABOMETYX - NOW APPROVED IN FIRST- LINE ADVANCED RCC
Dear Amy,
Exelixis® is pleased to announce an important update regarding the treatment of advanced renal cell carcinoma (RCC). CABOMETYX® (cabozantinib) is now FDA approved for the treatment of patients with advanced RCC—an expanded approval from the previous indication for patients who received prior anti-angiogenic therapy that was received in 2016.
This new approval makes CABOMETYX the first and only tyrosine kinase inhibitor (TKI) to surpass the efficacy of sunitinib as demonstrated in the randomized (1:1), open-label, multicenter CABOSUN trial of 157 patients with aRCC who had not received prior therapy.1*
PRIMARY ENDPOINT: CABOMETYX demonstrated a statistically significant improvement in median PFS vs sunitinib1†
CABOMETYX provided a significant 52% reduction in the risk of disease progression or death vs sunitinib            • Median PFS was            8.6 months with CABOMETYX and 5.3 months with sunitinib (HR=0.48; 95% CI: 0.31- 74; P=0.0008)
*Patients had ≥1 IMDC risk factors.1
PFS was assessed by a retrospective blinded IRRC.
PFS=progression-free survival; HR=hazard ratio; CI=confidence interval; IMDC=International Metastatic Renal Cell Carcinoma Database Consortium; IRRC=independent radiology review committee.
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SECONDARY ENDPOINT: OS1
Reduction in the risk of death was reported as 20%1
The hazard ratio for CABOMETYX vs sunitinib was 0.80 (95% CI: 0.53-1.21)1
The trial did not have a prespecified hypothesis for OS and statistical testing of this endpoint was not performed2,3
SECONDARY ENDPOINT: ORR1
CABOMETYX more than doubled ORR vs sunitinib1
ORR was 20% for CABOMETYX (95% CI: 12.0%-30.8%) vs 9% for sunitinib (95% CI: 3.7%-17.6%)1
As assessed by a retrospective blinded IRRC, all responses were partial responses
The trial did not have a prespecified hypothesis for ORR and statistical testing of this endpoint was not performed1,2
OS=overall survival; ORR=objective response rate.
No new safety signals were observed with CABOMETYX in the CABOSUN trial1
The most commonly reported (≥25%) adverse reactions are: diarrhea, fatigue, nausea, decreased appetite, hypertension, palmar-plantar erythrodysesthesia (PPE), weight decreased, vomiting, dysgeusia, and stomatitis
INDICATION
CABOMETYX® (cabozantinib) is a kinase inhibitor indicated for the treatment of patients with advanced renal cell carcinoma (RCC).
IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS
Hemorrhage: Severe and fatal hemorrhages have occurred with CABOMETYX. In RCC trials, the incidence of Grade ≥3 hemorrhagic events was 3% in CABOMETYX patients. Do not administer CABOMETYX to patients that have or are at risk for severe hemorrhage.
Gastrointestinal (GI) Perforations and Fistulas: In RCC trials, GI perforations were reported in 1% of CABOMETYX patients. Fatal perforations occurred in patients treated with CABOMETYX. In RCC studies, fistulas were reported in 1% of CABOMETYX patients. Monitor patients for symptoms of perforations and fistulas, including abscess and sepsis. Discontinue CABOMETYX in patients who experience a GI perforation or a fistula that cannot be appropriately managed.
Thrombotic Events: Thrombotic events increased with CABOMETYX. In RCC trials, venous thromboembolism occurred in 9% (including 5% pulmonary embolism) and arterial thromboembolism occurred in 1% of CABOMETYX patients. Fatal thrombotic events occurred in the cabozantinib clinical program. Discontinue CABOMETYX in patients who develop an acute myocardial infarction or any other arterial thromboembolic complication.
Hypertension and Hypertensive Crisis: Treatment-emergent hypertension, including hypertensive crisis, increased with CABOMETYX. In RCC trials, hypertension was reported in 44% (18% Grade ≥3) of CABOMETYX patients. Monitor blood pressure prior to initiation and regularly during CABOMETYX treatment. Withhold CABOMETYX for hypertension that is not adequately controlled with medical management; when controlled, resume CABOMETYX at a reduced dose. Discontinue CABOMETYX if there is evidence of hypertensive crisis or for severe hypertension that cannot be controlled with antihypertensive therapy or medical management.
Diarrhea: In RCC trials, diarrhea occurred in 74% of CABOMETYX patients. Grade 3 diarrhea occurred in 11% of CABOMETYX patients. Withhold CABOMETYX in patients who develop intolerable Grade 2 diarrhea or Grade 3-4 diarrhea that cannot be managed with standard antidiarrheal treatments until improvement to Grade 1; resume CABOMETYX at a reduced dose.
Palmar-Plantar Erythrodysesthesia (PPE): In RCC trials, PPE occurred in 42% of CABOMETYX patients. Grade 3 PPE occurred in 8% of CABOMETYX patients. Withhold CABOMETYX in patients who develop intolerable Grade 2 PPE or Grade 3 PPE until improvement to Grade 1; resume CABOMETYX at a reduced dose.
Reversible Posterior Leukoencephalopathy Syndrome (RPLS): RPLS, a syndrome of subcortical vasogenic edema diagnosed by characteristic finding on MRI, occurred in the cabozantinib clinical program. Evaluate for RPLS in patients presenting with seizures, headache, visual disturbances, confusion, or altered mental function. Discontinue CABOMETYX in patients who develop RPLS.
Embryo-fetal Toxicity: CABOMETYX can cause fetal harm. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during CABOMETYX treatment and for 4 months after the last dose.
ADVERSE REACTIONS
The most commonly reported (≥25%) adverse reactions were: diarrhea, fatigue, nausea, decreased appetite, hypertension, PPE, weight decreased, vomiting, dysgeusia, and stomatitis.
DRUG INTERACTIONS
Strong CYP3A4 Inhibitors: If concomitant use with strong CYP3A4 inhibitors cannot be avoided, reduce the CABOMETYX dosage.
Strong CYP3A4 Inducers: If concomitant use with strong CYP3A4 inducers cannot be avoided, increase the CABOMETYX dosage.
USE IN SPECIFIC POPULATIONS
Lactation: Advise women not to breastfeed while taking CABOMETYX and for 4 months after the final dose.
Hepatic Impairment: In patients with mild to moderate hepatic impairment, reduce the CABOMETYX dosage. CABOMETYX is not recommended for use in patients with severe hepatic impairment.
Please see full Prescribing Information.
If you’d like more information about the CABOSUN trial, feel free to contact your Exelixis® representative to schedule a visit.
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