From the American Thyroid Association:
In collaboration with the Food and Drug Administration (FDA), and as a service to our members, ATA will provide updates on recent FDA approvals and other important FDA actions (e.g., updated safety information, new prescribing information) pertaining to therapies for cancer patients. This will allow the agency to inform oncologists and professionals in oncology-related fields in a timely manner. Included in the email from the FDA will be a link to the product label or to other sites for additional relevant clinical information. The following is a message from the FDA’s Office of Hematology and Oncology Products Director, Dr. Richard Pazdur:
On February 13, 2015, the U. S. Food and Drug Administration approved lenvatinib (LENVIMA) for the treatment of patients with locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer.
The approval of lenvatinib was based on the demonstration of improved progression free survival (PFS) in a multicenter, double-blind, placebo-controlled trial (E7080-G00-303). The trial enrolled 392 patients with locally recurrent or metastatic radioactive iodine-refractory differentiated thyroid cancer and radiographic evidence of disease progression within 12 months prior to randomization. Patients were randomized (2:1) to receive either lenvatinib 24 mg orally per day (n = 261) or matching placebo (n = 131). Patients in the placebo arm were allowed to receive lenvatinib following independent radiologic confirmation of disease progression.
A statistically significant prolongation of PFS as determined by independent radiology review was demonstrated [HR 0.21 (95% CI: 0.16, 0.28); p < 0.001, stratified log-rank test]. Median PFS was 18.3 months in the lenvatinib arm and 3.6 months in the placebo arm. Objective response rates were 65% and 2% in the lenvatinib and placebo arms, respectively. No statistically significant difference in overall survival between the two arms was demonstrated. Upon confirmation of progression, 109 (83%) patients randomly assigned to placebo received open-label lenvatinib.
The most common adverse reactions, in order of decreasing frequency, observed in the lenvatinib treated patients were hypertension, fatigue, diarrhea, arthralgia/myalgia, decreased appetite, decreased weight, nausea, stomatitis, headache, vomiting, proteinuria, palmar-plantar erythrodysesthesia (PPE) syndrome, abdominal pain, and dysphonia. The most common serious adverse reactions were pneumonia (4%), hypertension (3%), and dehydration (3%).
Adverse reactions led to dose reductions in 68% of patients receiving lenvatinib and 18% of patients discontinued lenvatinib for adverse reactions.
The recommended dose of lenvatinib is 24 mg taken orally once daily. Treatment should continue until disease progression or unacceptable toxicity.
Full prescribing information is available at: http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206947s000lbl.pdf
Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System by completing a form online at http://www.fda.gov/medwatch/report.htm, by faxing (1-800-FDA-0178) or mailing the postage-paid address form provided online, or by telephone (1-800-FDA-1088).
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