FDA approves cobimetinib for histiocytic neoplasms
Click Here to Manage Email Alerts
The FDA granted accelerated approval to cobimetinib for treatment of certain patients of histiocytic neoplasms.
The indication applies to use of cobimetinib (Cotellic, Genentech) for adults with histiocytic neoplasms, including Erdheim-Chester disease, Rosai-Dorfman disease and Langerhans cell histiocytosis.
Cobimetinib, an oral inhibitor of MEK1 and MEK2, received prior FDA approval for treatment of melanoma.
The FDA approved the new indication based on data collected by Memorial Sloan Kettering Cancer Center in collaboration with Genentech from a single-institution phase 2 trial of single-agent cobimetinib for adults with histiocytic disorders.
“The approval of cobimetinib represents the collective hard work of several years of investigation by many [Memorial Sloan Kettering] researchers. There have been tremendous advances in the field of rare cancers as a result of research and trials conducted at [Memorial Sloan Kettering], and this approval is an excellent example of a practice-changing outcome,” Eli L. Diamond, MD, neuro-oncologist and neurologist at the cancer center and principal investigator of the trial said in a press release. “There has always been an unmet need for patients with histiocytosis, and we are thrilled that with this approval, these patients will now have access to a viable treatment option.”
Histiocytosis affects both children and adults. An estimated one or two of every 200,000 people are diagnosed each year.
The FDA previously approved vemurafenib (Zelboraf, Genentech) for treatment of Erdheim-Chester disease. Vemurafenib targets BRAF V600E mutations, found in more than half of histiocytosis cases.
“Until now, no standard therapy has existed for the 50% of histiocytosis patients without the BRAF V600E mutation,” Omar Abdel-Wahab, MD, a hematologic oncologist and director of Memorial Sloan Kettering’s Center for Hematologic Malignancies, said in the release. “The research pioneered at MSK has led to a viable treatment option for adult patients who harbor this mutation. Looking ahead, we are working on advancing treatment options for pediatric patients with histiocytosis as we have done in adults.”
Read more about
Click Here to Manage Email Alerts