The Committee for Medicinal Products for Human Use (CHMP) recommended European approval for Amgen’s Imlygic for melanoma and also advocated seven additional extensions on therapeutic indications.
Amgen’s Imlygic (talimogene laherparepvec) is seeking an indication for the treatment of adults with unresectable melanoma that is regionally or distantly metastic (stage IIIB, IIIC and IVM1a).
Novartis’ Cubicin (daptomycin) was backed for use in adults and paediatric patients with complicated skin and soft-tissue infections.
Novartis’s Cosentyx was also given a positive opinion (secukinumab) for the treatment of ankylosing spondylitis and psoriatic arthritis.
The CHMP also adopted a positive opinion on Janssen’s HIV drug Edurant (rilpvirine) for the treatment of adolescents aged between 12 and 18. It is currently estimated that one in seven of all new HIV infections occur in adolescence and young adulthood.
Merck Sharpe & Dohme’s Emend (aprepitant) was further recommended for the prevention of nausea and vomiting in child chemotherapy patients from the age of 6 months to 12 years.
Pfizer’s Volibris (ambrisentan) was backed for the treatment of pulmonary arterial hypertension (PAH) with efficacy being shown in idiopathic PAH and PAH associated with connective tissue disease.
Pfizer also received backing for Xalkori (crizotinib) for the first-line treatment of adults with anaplastic lymphoma kinase (ALK) positive advanced non-small cell lung cancer (NSCLC).
CHMP Warnings
The CHMP also proposed the suspension of Medtronic’s Inductos – an implant used to help new bone development in patients with spinal disc problems and leg fractures. Although there has been no indication of risk to patients, the suspension comes from the way the absorbable sponge is manufactured.
The Committee also advocated additional measures to prevent the use of Roche’s Cellcept (mycophenolate) during pregnancy. Evidence has suggested an increased risk of birth defects and spontaneous abortions when pregnant women are exposed to the medication.
New advice has also been issued on the use of Biogen’s Tecfidera (dimethyl fumarate). The regulatory advisors want to see a complete blood count performed before treatment is started and every three months to minimise the risk of progressive multifocal leukoencephalopathy (PML) in patients with multiple sclerosis.