FDA approves everolimus tablets (AFINITORR, Novartis) for treatment of patients with advanced renal cell carcinoma after failure of treatment with sunitinib or sorafenib

ASCO SIGN IN

Manage Email Subscriptions

Username:

Create an account

Why Be A Member?

Password:

Remember me

Forgot your username or password?

ASCO Membership Directory

The Remember Me feature is an automatic login process which creates a cookie on the hard drive of your computer containing a unique identifier which ASCO.org will utilize to remember you by, thereby avoiding the need to enter username and password upon subsequent visits to ASCO.org. DO NOT select this option if you share this computer with others since transactional, personal, or member only information will be accessible by other users.

To activate the Remember Me option, click the empty check box when signing in to the site. The Remember Me functionality is deactivated at the logout.

For additional information please review our Privacy Policy.

ASCO Home

Practice & Guidelines

Practice Management & Reimbursement

FDA Drug Alerts

FDA approves everolimus tablets (AFINITORR, Novartis) for treatment of patients with advanced renal cell carcinoma after failure of treatment with sunitinib or sorafenib

On March 30, 2009, the U. S. Food and Drug Administration granted approval to everolimus tablets (AFINITOR®, Novartis Pharmaceuticals Corporation) for the treatment of patients with advanced renal cell carcinoma after failure of treatment with sunitinib or sorafenib.

The efficacy and safety of everolimus were evaluated in an international, multicenter, randomized, double-blind trial comparing everolimus to placebo. All patients received best supportive care. The trial was conducted in patients with metastatic renal cell carcinoma after failure of treatment with sunitinib or sorafenib. Prior therapy with bevacizumab, interleukin-2, or interferon-a was also permitted. Randomization was stratified according to prognostic score and prior anticancer therapy.

A total of 416 patients were randomized (2:1) to receive everolimus (n=277) or placebo (n=139). Demographics were well balanced between the two arms. Progression-free survival (PFS) was the trial’s primary endpoint. The median PFS was 4.9 and 1.9 months in the everolimus and placebo arms, respectively (HR = 0.33, p value < 0.0001). The treatment effect was similar across prognostic scores and prior treatment status. The overall survival results were not mature; 32% of patients had died by the time of data cut-off. The objective response rates were 2% and 0% for everolimus and placebo, respectively. After documented radiological progression, patients receiving placebo could receive everolimus.

The most common adverse reactions (incidence =30%) were stomatitis, infections, asthenia, fatigue, cough, and diarrhea. The most common grade 3/4 adverse reactions (incidence =3%) were infections, dyspnea, fatigue, stomatitis, dehydration, pneumonitis, abdominal pain, and asthenia. Anemia, hypercholesterolemia, hypertriglyceridemia, hyperglycemia, lymphopenia, and increased creatinine were the most common laboratory abnormalities (incidence =50%). The most common grade 3/4 laboratory abnormalities (incidence =3%) were lymphopenia, hyperglycemia, anemia, hypophosphatemia, and hypercholesterolemia. Deaths due to acute respiratory failure (0.7%), infection (0.7%) and acute renal failure (0.4%) occurred on the everolimus arm but not on the placebo arm.

The recommended dose of everolimus for treatment of advanced renal cell carcinoma is 10 mg once daily at the same time either with or without food.

Full prescribing information, including clinical trial information, safety, dosing, drug-drug interactions and contraindications is available on the FDA website.