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CHMP backs three immuno-oncology drugs for solid tumours

Roche, MSD and Merck/Pfizer are all on course for new European approvals later this year

EMARoche, MSD and Merck/Pfizer all picked up positive opinions for cancer immunotherapies from EMA advisors last week, setting up approvals in the third quarter.

The Committee for Medicinal Products for Human Use (CHMP) recommended approval of Merck KGaA and Pfizer's Bavencio (avelumab) for Merkel cell carcinoma (MCC) - a rare form of skin cancer - which is the first indication for the PD-L1 inhibitor in the EU. In the US, Bavencio is already approved to treat both MCC and metastatic urothelial carcinoma (bladder cancer), and the latter indication is also under EMA review.

Roche has picked up a green light from the CHMP for its PD-L1 inhibitor Tecentriq (atezolizumab) for second-line treatment of mUC and non-small cell lung cancer (NSCLC), its first two indications in the EU. Once again, the drug is already approved for both those indications in the US. The approval in bladder cancer comes shortly after Roche reported that Tecentriq failed to meets its objectives in a trial intended to firm up its earlier conditional approval by the US FDA.

Meanwhile MSD - known as Merck & Co in the US - has bagged a positive opinion for its PD-1 inhibitor Keytruda (pembrolizumab) for the second-line treatment of bladder cancer in adults who have either been treated before with platinum-based chemotherapy or cannot tolerate that type of treatment. It's already been approved for melanoma, non-small cell lung cancer and classical Hodgkin lymphoma by the EMA.

The crop of new immuno-oncology positive opinions was also accompanied by recommendations for targeted cancer drugs, including Novartis' Rydapt (midostaurin) which is now on course to become the treatment for newly diagnosed FLT3-mutated acute myeloid leukaemia (AML) in the EU, just weeks after getting the nod from the FDA.

Advanced Accelerator Applications secured a recommendation for Lutathera (lutetium [177Lu] oxodotreotide) - for the treatment of gastro-entero-pancreatic neuroendocrine tumours - and Ipsen got the nod for Xermelo (telotristat ethyl) as a treatment for carcinoid syndrome, a set of debilitating symptoms seen in patients with carcinoid tumours.

Away from the cancer field, Johnson & Johnson's Janssen pharma unit got a positive opinion for Symtuza, the first complete, single-tablet HIV regimen based on its big-selling protease inhibitor Prezista (darunavir). The once-daily product combines darunavir with cobicistat, emtricitabine and tenofovir alafenamide (TAF) and is vying to compete with therapies from GlaxoSmithKline's ViiV unit.

The CHMP also recommended granting a marketing authorisation for Verkazia (ciclosporin), an orphan medicine to treat the rare and chronic eye allergy vernal keratoconjunctivitis in children and adolescents that can lead to corneal ulcers and loss of sight. The drug was reviewed under EMA's accelerated assessment mechanism.

Article by
Phil Taylor

24th July 2017

From: Regulatory



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