Keytruda, Nivolumab and Unituxin are amongst eight new medicines recommended for approval at this month’s meeting of the Committee for Medicinal Products for Human Use (CHMP).
Merck’s Keytruda (pembrolizumab) has been granted positive opinion to treat advanced melanoma, news that will further please the company following a head-to-head trial with BMS’ Yervoy where it outperformed the world’s biggest selling melanoma drug.
Nivolumab BMS (nivolumab) received positive opinion to treat adults with squamous non-small lung cancer (NSCLC), while Unituxin (dinutiximab) was given the nod for the treatment of high-risk neuroblastoma, a cancer that is most common in young children.
Further recommendations
Away from immunotherapies, the Committee gave marketing authorisation for Repatha (evolocumab), a first-in-class treatment to lower high levels of cholesterol in the blood of patients where statins are ineffective or who cannot take statins.
Repatha is the first monoclonal antibody in this therapeutic area and is additionally recommended to treat homozygous familial hypercholesterolaemia, a rare inherited disease.
The CHMP also recommended BMS’ Evotaz (atazanavir/cobicistat) for HIV-1 infected adults without known mutations associated with resistance to atazanavir, further good news for the company following the FDA’s approval for the same indication earlier this year.
Omidria (phenylephrine/ketorolac) received a positive opinion from the Committee for maintenance of intraoperative mydriasis, prevention of intraoperative miosis and reduction of acute postoperative ocular pain in intraocular lens replacement surgery.
Finally, two generic medicines gained positive opinions: Bortezomib Accord (bortezomib) for the treatment of multiple myeloma and mantle cell lymphoma and Pregabalin Zentiva (pregabalin) for the treatment of epilepsy and generalised anxiety disorder.