Eleven new medicines have been recommended for approval in Europe, including two new cancer drugs: Roche’s Kadcyla and Bayer’s Xofigo.
Kadcyla (trastuzumab emtansine or T-DM1) is the first antibody-drug conjugate for advanced HER2-positive breast cancer, and is under review as a single agent for the treatment of adults with unresectable locally advanced or metastatic disease, who have previously received trastuzumab and/or a taxane.
Endorsement by the Committee for Medicinal Products for Human Use (CHMP) comes on the back of clinical data from the international, Phase III EMILIA study, in which the drug helped this subset of patients live for nearly 10 months without their disease getting worse and extended life expectancy to more than two and a half years overall (30.9 months).
According to Roche, Kadcyla has also demonstrated a tolerable safety profile and is linked with fewer of the severe side effects usually experienced with current chemotherapies.
Bayer’s Xofigo was given the nod for the treatment of adults with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastases.
Phase III trial data showed that men taking Xofigo, which is based on radium 223, lived a median of 14 months compared to 11.2 months for those receiving a placebo, findings which supported the drug’s US approval back in May.
Xofigo works by binding with minerals in the bone to deliver radiation directly to bone tumours, which thereby can limit damage to the healthy surrounding tissues and seems to have a beneficial impact on overall survival.
Elsewhere, the Committee also gave positive recommendations to three neurological therapies: Otsuka/Lundbeck’s once-monthly Abilify Maintena (aripiprazole) for the treatment of schizophrenia; Accord Healthcare’s generic Memantine Accord (memantine), for the treatment of Alzheimer’s disease; and Orion’s Levodopa Carbidopa Entacapone Sandoz, which was submitted as a so-called informed consent application, for the treatment of adult patients with Parkinson’s disease.
Gilead’s Vitekta (elvitegravir) got a thumb’s up for the treatment of human immunodeficiency virus_1 (HIV_1) infection in adults who are infected with HIV_1 without known mutations associated with resistance to the drug. This is particularly good news for the firm, given that US regulators turned down Vitekta in April, noting deficiencies in documentation amongst other things.
Janssen-Cilag’s Invokana (canagliflozin) received a positive opinion for the treatment of type 2 diabetes. The drug, which was approved in the US in April, is a sodium-glucose co-transporter 2 (SGLT2) inhibitor that works by blocking the reabsorption of glucose by the kidney, increasing glucose excretion, and lowering blood glucose levels.
Novo Nordisk’s NovoEight was also put forward by the CHMP for the treatment of haemophilia A, while GlaxoSmithKline’s Relvar Ellipta won favour as a treatment for asthma and chronic obstructive pulmonary disorder (COPD).
AstraZeneca’s four-strain nasal spray vaccine Fluenz Tetra was recommended for the prevention of influenza in children and adolescents 24 months to less than 18 years of age.
The jab contains two strains of influenza A and two strains of influenza B (instead of the usual one) to provide broad protection against latter, which accounts for around 25% of the influenza strains that circulate in Europe.
Finally, the Committee also concluded that Plethora’s Lidocaine/Prilocaine Plethora should be granted marketing authorisation for primary premature ejaculation in adult men.
