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Keytruda and Opdivo backed for new uses in Europe

CHMP recommendations also include Trumenba, Dinutuximab beta and Refixia


MSD and Bristol-Myers Squibb (BMS) both picked up positive opinions for their PD-1 inhibitors from the EMA's advisory committee last week.

The Committee for Medicinal Products for Human Use (CHMP) gave a green light to MSD's Keytruda (pembrolizumab) for the treatment of patients with relapsed or refractory classical Hodgkin's lymphoma (cHL), shortly after the FDA cleared the drug for the same blood cancer in the US. Keytruda is cleared for use in adults who have failed a stem cell transplant and have already tried or are ineligible for Takeda's Adcetris (brentuximab vedotin).

BMS' Opdivo (nivolumab) - which is already approved in the EU for cHL - was given the nod for the treatment for adults with squamous cell cancer of the head and neck whose disease has progressed on or after platinum-based chemotherapy. It is the first immuno-oncology drug approved for head and neck cancer in the EU, and was cleared in the US for the same indication last year.

At its meeting last week the CHMP also backed the approval of Pfizer's meningococcal group B (MenB) vaccine Trumenba, which will provide the first alternative to GlaxoSmithKline's fast-growing Bexsero, which has been held back somewhat by tight supply, in older children. Trumenba has been approved for children aged 10 years or older, while Bexsero can be administered from two months.

Novo Nordisk picked up a positive opinion for Refixia (nonacog beta pegol), its long-acting factor IX replacement therapy for haemophilia B. The drug's half-life is around five times longer than standard factor IX products, meaning fewer injections are needed, and the company is hoping that the new product will help defend its franchise from rival long-acting haemophilia B drug Alprolix (eftrenonacog alfa) from Biogen and Swedish Orphan Biovitrum which was approved in the EU last year.

Apeiron Biologics also got the go-ahead for Dinutuximab beta as a treatment for high-risk neuroblastoma, an orphan indication. The positive opinion was granted under exceptional circumstances – a designation which provides access to drugs that cannot be approved under a standard authorisation as sufficient data cannot be obtained.

Exceptional approvals are subject to confirmatory data and are generally given when there are only very few patients with the disease, the collection of complete information on the efficacy and safety of the medicine would be unethical, or there are gaps in the scientific knowledge, said the CHMP.

Meanwhile, the CHMP also said that PTC Therapeutics has withdrawn its application to extend the indications for its Duchenne muscular dystrophy (DMD) drug Translarna (ataluren) to include patients with cystic fibrosis caused by a nonsense mutation. The panel said that based on the data provided to date it was not of the opinion that the drug's benefits outweighed its risks in CF.

Article by
Phil Taylor

27th March 2017

From: Regulatory



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