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The Committee for Medicinal Products for Human Use (CHMP) has given a positive opinion recommending Novartis’s Kymriah (tisagenlecleucel) to treat two aggressive blood cancers.
The CHMP, which is part of the European Medicines Agency (EMA), gave a positive opinion on using tisagenlecleucel to treat B-cell acute lymphoblastic leukaemia (ALL) that is refractory, in relapse post-stem cell transplant or in second or later relapse in patients up to 25 years of age.
It also gave a positive opinion on using the drug to treat diffuse large B-cell lymphoma (DLBCL) that is relapsed or refractory (r/r) after two or more lines of systemic therapy in adults.
The drug – a type of CAR-T (Chimeric Antigen Receptor – T cell) – treats blood cancers by ‘reprogramming’ the patient’s white blood cells to recognise and fight cancer.
Professor Ajay Vora, consultant paediatric haematologist at Great Ormond Street Hospital, said: “There has been an urgent need for new types of treatment options that improve outcomes for patients with relapsed or refractory B-cell precursor ALL. These young patients have a poor prognosis, often undergoing multiple treatments, yet less than 10 per cent survive for five years.
“The CHMP positive opinion for tisagenlecleucel is the first step towards providing UK patients with access to a licensed therapy that provides a new option for children and young adults with this disease, which has only so far been available through research trials.”