BETHESDA, MD 30 November 2012—FDA on November 29 announced the approval of cabozantinib oral capsules for the treatment of progressive, metastatic medullary thyroid cancer, a rare type of malignancy.
The drug will be sold as Cometriq by Exelixis of South San Francisco, California. Excelixis Chief Commercial Officer J. Scott Garland announced that the company is targeting a late-January launch date for the product.
for cabozantinib states that the drug inhibits the tyrosine kinase activity of several proteins that affect normal cellular function as well as processes that affect tumors.
Cabozantinib was approved on the basis of data from a placebo-controlled trial involving 330 patients with progressive, metastatic medullary thyroid cancer. The trial was designed primarily to assess progression-free survival.
In this study, patients treated with cabozantinib lived for an average of 11.2 months before tumor growth occurred, compared with 4 months for patients receiving a placebo. Tumor shrinkage occurred in about a quarter of patients treated with cabozantinib, but the treatment did not extend peoples' lives.
A boxed warning in the labeling for cabozantinib states that gastrointestinal perforations and fistulas, some of them fatal, have been reported in patients treated with the drug, as have severe and fatal cases of hemorrhage.
Other adverse events reported in patients treated with cabozantinib include diarrhea, mouth sores, weight loss, nausea, fatigue, hair color changes, new or worsening hypertension, abdominal pain, and constipation.
The labeling states that cabozantinib therapy should be discontinued if certain conditions occur—specifically, fistula, gastrointestinal perforation, severe bleeding, myocardial infarction or serious arterial thromboembolic events, hypertensive crisis, osteonecrosis of the jaw, nephrotic syndrome, or reversible posterior leukoencephalopathy syndrome.
Cabozantinib should not be used in patients with moderate or severe liver impairment. Situations that necessitate dosage reductions or therapy interruption are described in the labeling.
The recommended starting dosage of cabozantinib is 140 mg, administered as one 80-mg capsule and three 20-mg capsules, taken without food. Patients should not eat for at least two hours before taking cabozantinib and one hour after taking the drug.
Treatment should continue until the cancer progresses or unacceptable toxicity occurs.
Cabozantinib capsules will be formulated in 20- and 80-mg strengths. The drug will be packaged in cartons containing four blister cards of capsules arranged to supply a daily dose of 60, 100, or 140 mg of the drug. Each blister card will contain one weeks' worth of therapy. Cabozantinib will also be packaged in bottles of 60 20-mg capsules.
The capsules should be stored at controlled room temperature.