Roche’s New Melanoma Drug, Cotellic, Gets FDA Approval

Roche’s New Melanoma Drug, Cotellic, Gets FDA Approval

Roche recently announced that the U.S. Food and Drug Administration (FDA) approved Cotellic (cobimetinib) used in combination with Zelboraf (vemurafenib) for the treatment of patients with BRAF V600E or V600K mutation-positive unresectable or metastatic melanoma.

Cotellic is an antineoplastic agent blocking the mitogen-activated protein kinase (MAPK) pathway by targeting MEK1 and MEK2 kinases, thereby inhibiting intracellular signaling and decreasing tumor cell proliferation, while delaying the onset of melanoma resistance when compared to BRAF inhibitor monotherapy (vemurafenib). “When used in combination, Cotellic and Zelboraf help delay disease progression and help people live significantly longer than with Zelboraf alone,” Sandra Horning, MD, Chief Medical Officer and Head of Global Product Development, said in a press release. “With this approval, people with this type of deadly and aggressive skin cancer now have a new targeted option.”

The FDA approval was based on results from the Phase 3 coBRIM clinical trial, which revealed Cotellic in combination with Zelboraf significantly reduced the risk of death or disease progression (progression-free survival, or PFS) by nearly half in patients treated with the combination drugs. Results from an interim analysis also revealed that combination treatment helped patients live significantly longer and had increased tumor shrinkage when compared to Zelboraf alone.

The final overall survival results of the coBRIM trial will be  presented during the 2015 International Congress of the Society for Melanoma Research (SMR), set for Nov. 18–21, 2015, in San Francisco, California.

In September, the Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA) released a positive opinion on Roche’s marketing authorization application for Cotellic in the European Union. A decision from the European Commission is anticipated before the end of the year.

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Caladrius Biosciences, Inc., recently presented novel data at the 2015 Annual Meeting of the Society for Immunotherapy of Cancer (SITC), which took place in Baltimore, Maryland, on Nov. 4-8, 2015.

The clinical and analytic results were drawn from a concluded Phase 2 clinical trial and provide evidence that supports the technology currently being evaluated in an enrolling Phase 3 trial assessing the company’s lead investigational candidate, CLBS20, for the treatment of metastatic melanoma.

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