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FDA approves Afinitor to treat advanced neuroendocrine tumors of gastrointestinal, lung origin
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The FDA today approved everolimus to treat adult patients with progressive, well-differentiated, nonfunctional neuroendocrine tumors of gastrointestinal or lung origin that are unresectable, locally advanced or metastatic.
The FDA based its decision in part on results from the RADIANT-4 trial, a multicenter, randomized, placebo-controlled trial of 302 patients with unresectable, locally advanced or metastatic, well-differentiated nonfunctional neuroendocrine tumors of gastrointestinal or lung origin. All patients had experienced disease progression within 6 months of randomization.
Researchers randomly assigned patients 2:1 to receive best supportive care plus 10 mg of everolimus (Afinitor, Novartis) orally once daily or a placebo. Patients received treatment over a median of 9.3 months.
Patients in the everolimus group achieved longer median PFS compared with patients in the placebo group (11 vs. 3.9 months; HR = 0.48, 95% CI, 0.35-0.67). The overall response rate was 2% in the everolimus arm and 1% in the placebo arm.
In total, serious adverse events occurred in 42% of everolimus-treated patients, including three fatal events. Twenty-nine percent of patients discontinued treatment and 70% reduced or delayed treatment.
The most common adverse reactions included stomatitis, infections, diarrhea, peripheral edema, fatigue and rash. The most common laboratory abnormalities were anemia, hypercholesterolemia, lymphopenia, elevated aspartate transaminase and fasting hyperglycemia.
“Afinitor is the first treatment approved for progressive, nonfunctional [neuroendocrine tumors] of lung origin, and one of very few options available for progressive, nonfunctional [gastrointestinal neuroendocrine tumors], representing a shift in the treatment paradigm for these cancers,” Bruno Strigini, president of Novartis Oncology, said in a press release. “We are proud of our Afinitor development program, which has translated to meaningful benefits for patients with several different cancers and rare diseases.”
Everolimus also is approved in the U.S. for the treatment of locally advanced, metastatic or unresectable progressive neuroendocrine tumors of pancreatic origin, as well as for advanced renal cell carcinoma following progression on or after sunitinib and sorafenib (Nexavar, Bayer Healthcare).