Posted by Michael Wonder on 30 Jun 2018
Novartis receives positive CHMP opinion for Kymriah for treating two aggressive blood cancers, marking important medical advance for patients in Europe
29 June 2018 - First CHMP opinion for a CAR-T cell therapy in two distinct indications - DLBCL in adults and B-cell ALL in children.
Novartis today announced that the CHMP of the EMA adopted a positive opinion recommending approval of Kymriah (tisagenlecleucel, formerly CTL019) - a novel one-time treatment that uses a patient's own T cells to fight cancer. The positive opinion includes two B-cell malignancies: B-cell acute lymphoblastic leukaemia (ALL) that is refractory, in relapse post-transplant or in second or later relapse in patients up to 25 years of age; and diffuse large B-cell lymphoma (DLBCL) that is relapsed or refractory after two or more lines of systemic therapy in adults.
The positive CHMP opinion is based on two pivotal Novartis-sponsored global, multi-center, Phase II trials, ELIANA and JULIET, which included patients from Europe, the US, Australia, Canada and Japan.
