Based on a recently completed analysis of data from the CAMELLIA-TIMI 61 trial, Eisai, the manufacturer of Belviq (lorcaserin HCl) and Belviq XR (lorcaserin HCl extended-release), has decided to withdraw both weight-loss agents from the market.
Earlier this year, the Food and Drug Administration (FDA) had issued a safety communication regarding the potential link between lorcaserin use and increased cancer risk. Data obtained from the CAMELLIA-TIMI 61 trial, a large postmarketing study conducted in roughly 12,000 patients, found that over a 5-year follow-up period, a greater proportion of patients taking the drug had been diagnosed with cancer compared with those who received placebo (7.7% vs 7.1%, respectively). Cancer types reported more frequently in the lorcaserin group included pancreatic, colorectal, and lung cancer. Study findings also showed the imbalance in cancer cases increased with longer duration of therapy.
In a press release, Eisai stated that the Company’s interpretation of the data from the CAMELLIA-TIMI 61 trial differed from the FDA’s:
The Company’s assessment is that Belviq and Belviq XR continue to have a positive benefit-risk profile in the patient population for which they are indicated. However, based on the change in FDA’s risk-benefit assessment and as requested by the Agency, Eisai has agreed to voluntarily withdraw the products from the US market.
The FDA is advising healthcare professionals to stop prescribing lorcaserin to patients and to contact those who have been treated with the drug. Patients should be informed of the increased occurrence of cancer observed in the clinical trial, however, the Agency is not recommending special screening. Alternative weight-loss medications or strategies should be discussed with patients.
For more information visit fda.gov.