![]() But FDA examined all adverse events post-randomization in the study, rather than just "on treatment" events, wherein the signal for an increased cancer risk emerged. In the published data for the safety trial, which focused on lorcaserin's effect on major adverse cardiovascular events, no increased cancer risk was seen. Participant smoking status and cancer history had been well balanced between the two arms. The postmarketing study was designed to assess cardiovascular safety, of which it met its goal, and was not powered to assess cancer endpoints. The agency's decision was based on findings from CAMELLIA-TIMI 61, a randomized placebo-controlled trial, which from 2014 to 2018 randomized 12,000 patients 1:1 to either lorcaserin or placebo. Some neoplasms were less common in the lorcaserin group, including prostate (61 vs 70), endometrial (6 vs 13), and bladder (7 vs 13) cancers. and remission of type 2 diabetes in overweight and obese patients (CAMELLIA-TIMI 61): a randomised, placebo-controlled trial, apppearing in the Lancet. But point estimates from 180 to 900 days from randomization (taken every 60 days) were consistently above 1.0, the authors noted.Ĭolorectal cancer occurred more frequently in the lorcaserin group, with 26 versus 14 with placebo, as did pancreatic cancer (16 vs 2, respectively), lung cancer (40 vs 25), leukemia (12 vs 6), hepatobiliary cancers (10 vs 4), and others. While acknowledging that the observed cancer risk was low, the FDA reviewers concluded that the drug's potential benefits do not outweigh these risks.ĭuring the first 180 days of the trial, new cancer cases were similar between the two groups (76 and 77 in the investigational and placebo arms, respectively). Overall, patients on lorcaserin had a slightly higher, though non-significant, rate of any cancer versus placebo patients (rate ratio 1.09, 95% CI 0.96-1.24), which increased when excluding common skin cancers (RR 1.16, 95% CI 0.98-1.36). "Cancer risk may also be higher among patients using lorcaserin over the long term." "The agency recognizes the importance of weight-loss therapies, but the magnitude of clinical benefit associated with modest weight reduction is uncertain, and this benefit may manifest only after years of sustained weight loss," the group wrote. At a median of 3.3 years follow-up, 52 deaths (0.9%) from cancer occurred among patients on lorcaserin versus 33 with placebo (0.6%), as described in the New England Journal of Medicine.
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