EMA Recommends Advanced Therapy for Melanoma

The European Medicines Agency announced on Oct. 23, 2015 that the Committee for Medicinal Products for Human Use (CHMP) is recommending Imlygic (talimogene laherparepvec) for the treatment of adults with melanoma that cannot be surgically removed and has spread to other areas of the body. Imlygic is a first-in-class advanced therapy product derived from a genetically engineered product designed to kill cancer cells. The recommendation came during a meeting of CHMP from Oct. 19-22, 2015. 

Other outcomes from the CHMP meeting included the extension of indications for several products including Cubicin, Eddurant, Emend, Volibris, and Xalkori, as well as two extensions of indication for Cosentyx. The committee also issued a final negative opinion for Heparesc (human heterologous liver cells) after the conclusion of a re-examination procedure.

After reassessing the benefits and risks of mycophenolate, a transplant medicine, the CHMP issued a warning that women who are pregnant should not use the medicine unless an alternative in unavailable, due to evidence that exposure to the medicine may cause birth defects or spontaneous abortions. The committee also gave an update on risks involved with HIV treatments.

More information on the CHMP meeting can be found on EMA’s website. 

Source: EMA