Novartis Leads Pipeline NewsBy
A roundup of the latest market developments from the pipelines of the pharmaceutical majors, featuring news from Novartis.
Editor’s Note: This article was updated on a continuous basis for news announced from Wednesday, January 17, 2017 to Tuesday, January 23, 2017.
FDA Grants Novartis Priority Review for New Use of CAR-T Therapy Kymriah
The US Food and Drug Administration (FDA) has granted priority review for Novartis’ supplemental biologics license application for the company’s chimeric antigen receptor T cell (CAR-T) therapy, Kymriah (tisagenlecleucel), for treating adult patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL) who are ineligible for or relapse after autologous stem cell transplant (ASCT).
In August 2017, Kymriah became the first CAR-T therapy approved in the US when it received FDA approval for treating patients up to 25 years of age with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or has relapsed at least twice. Kymriah is a treatment that uses a patient’s own T cells to fight cancer.
In addition, the European Medicines Agency has granted accelerated assessment to the marketing authorization application for Kymriah for treating children and young adults with r/r B- ALL and for adult patients with r/r DLBCL who are ineligible for ASCT. Priority review and accelerated assessment are granted to therapies that may provide a significant improvement in the safety and effectiveness of treating a disease, and the designations are intended to expedite the standard review time.
In 2012, Novartis and the University of Pennsylvania entered into a global collaboration to further research, develop, and commercialize CAR-T cell therapies, including Kymriah, for the investigational treatment of cancers. Novartis plans additional regulatory submissions for Kymriah in pediatric and young adult patients with r/r B-cell ALL and adult patients with r/r DLBCL beyond the US and European Union in 2018.