Cancer Risk Associated with Lorcaserin — The FDA’s Review of the CAMELLIA-TIMI 61 Trial

This perspective details the FDA’s 2020 decision to withdraw the weight-loss drug lorcaserin (Belviq) from the U.S. market due to cancer risks identified in the postmarketing CAMELLIA TIMI 61 trial. The trial, involving 12,000 participants, revealed higher rates of total cancers (7.7% vs. 7.1%), cancer deaths (0.9% vs. 0.6%), and specific malignancies (e.g., colorectal, pancreatic, and lung cancers) in the lorcaserin group compared to placebo. The FDA’s analysis, which included postrandomization events and accounted for latency periods, supported a plausible drug associated risk. Despite lorcaserin’s modest weight loss benefits (median 3% placebo-adjusted reduction), the agency concluded its risks outweighed benefits, leading to voluntary market withdrawal.

This perspective details the FDA’s 2020 decision to withdraw the weight-loss drug lorcaserin (Belviq) from the U.S. market due to cancer risks identified in the postmarketing CAMELLIA TIMI 61 trial. The trial, involving 12,000 participants, revealed higher rates of total cancers (7.7% vs. 7.1%), cancer deaths (0.9% vs. 0.6%), and specific malignancies (e.g., colorectal, pancreatic, and lung cancers) in the lorcaserin group compared to placebo. The FDA’s analysis, which included postrandomization events and accounted for latency periods, supported a plausible drug associated risk. Despite lorcaserin’s modest weight loss benefits (median 3% placebo-adjusted reduction), the agency concluded its risks outweighed benefits, leading to voluntary market withdrawal.