FDA approves Cotellic for the treatment of adult patients with histiocytic neoplasms
The FDA has approved cobimetinib (Cotellic) for the treatment of adult patients with histiocytic neoplasms, which include Erdheim-Chester disease, Rosai-Dorfman disease, and Langerhans cell histiocytosis
The regulatory decision was based on data collected through a collaborative effort between Memorial Sloan Kettering (MSK) Cancer Center and Genentech. Data from the single-center, single-arm trial showed that at a median follow-up of 11.4 months (range, 0.2-36.8), cobimetinib elicited an objective response rate (ORR) of 76.9% (n = 20; 95% CI, 56.4%-91.0%) by PET and 46.2% (n = 12; 26.6%-66.6%) by RECIST criteria in 26 enrolled patients.
The trial enrolled adult patients with histologically confirmed histiocytic neoplasms of any mutational status. Notably, those with documented BRAF V600E mutations were permitted if they were unable to access a BRAF inhibitor or if they discontinued a BRAF inhibitor because of toxicity.
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