FDA says benefits of lorcaserin do not outweigh risk of cancer
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FDA says benefits of lorcaserin do not outweigh risk of cancer The potential benefits of lorcaserin for long-term weight management in overweight and obese patients do not outweigh the risk of cancer, according to findings of a review by the US FDA of the CAMELLIA-TIMI 61 trial published in the New England Journal of Medicine. Esai, the manaufacturer of lorcaserin [Belviq] and lorcaserin extended-release [Belviq XR], voluntarily withdrew the products from the US market in February 2020 after a request by the FDA after reviewing the benefits and risks of lorcaserin in the CAMELLIA-TIMI 61 trial. The FDA did not approve the original marketing application from Arena Pharmaceuticals for lorcaserin because carcinogenicity studies in rats had found an increased incidence of tumours. After further nonclinical and clinical data were submitted, the FDA approved the drug in June 2012 on the condition that a postmarketing study on cardiovascular safety was conducted. The double-blind CAMELLIA-TIMI 61 trial was conducted between 2014 and 2018 and investigated the incidence of major adverse cardiovascular events (MACE) in patients randomised to lorcaserin (n=6000) or placebo (6000). It was not powered for cancer endpoints. The trial met the MACE safety endpoint and did not report any cancer signal. In initial safety analyses of all adverse events reported after randomisation in the CAMELLIA trial, the FDA identified a potential signal for an increased risk of cancer and cancer-related death and therefore requested additional information from the company for a full review. Overall, the FDA identified 990 diagnoses of cancer in 885 trial participants. Cancer was diagnosed in 7.7% of lorcaserin-treated patients and 7.1% of placebo recipients, and cancer-related death was reported in 0.9% and 0.6% of patients, respectively. Of note, the incidence of colorectal cancer (n=26 vs 14), lung cancer (40 vs 25) and pancreatic cancer (16 vs 2) was higher in lorcaserin-treated patients. However, the overall risk of any cancer or malignant neoplasms (excluding common skin cancers) was not significantly higher with lorcaserin versus placebo. "In keeping with a long-latency safety signal, cancer risk was elevated among patients in the lorcaserin group for all latency periods beyond 180 days," noted the authors. "We recognize that the observed excess cancer risk in the trial was not large. Balancing the clinical importance of cancer and the difficulty of mitigating this risk against the uncertain clinical benefit of lorcaserin, however, we conclude that the therapy’s benefits do not outweigh the risks for any identifiable patient population," they concluded. Sharretts J, et al. Cancer Risk Associated with Lorcaserin - The FDA’s Review of the CAMELLIA-TIMI 61 Trial. New England Journal of Medicine 383: 1000-1002, No. 11, 803502403 10 Sep 2020. Available from: URL: http://doi.org/10.1056/NEJMp2003873
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