EMA Highlights by Gary Finnegan – At its April meeting, the EMA’s influential Committee for Medicinal Products for Human Use (CHMP) recommended that a marketing authorisation be granted for Mekinist (trametinib).
Mekinist is recommended for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation. It is the first cancer treatment that selectively targets the MEK protein kinase.
This was the only new product approved in April but several new indications and extensions were granted. The Committee recommended adding a new indication to the use of the cancer medicine Nexavar (sorafenib) to treat progressive, locally advanced or metastatic, differentiated thyroid cancer.
It also recommended extensions of indications for Gilenya, Invega, Pradaxa, Prolia, Gardasil and Silgard.
The CHMP discussed the recent theft of vials of the anticancer medicine Herceptin 150 mg. The vials, after being stolen in Italy, were tampered with and re-introduced under false credentials into the supply chain in some countries. The Committee agreed to alert healthcare professionals in concerned Member States.
A document listing the batches of Herceptin (trastuzumab), Alimta (pemetrexed) and Remicade (infliximab) that are the subject of ongoing investigations into the theft of vials of these medicines in Italy, has been published on the EMA website.