The FDA Scheduled to Review Novartis’ Gene Therapy Drug on Wednesday

Published on: 11 Jul, 2017

Novartis AG (NYSE: NVS) is engaged in the research, development, manufacturing and marketing of a range of healthcare products led by pharmaceuticals. The U.S. Food and Drug Administration will ask a panel of advisers to focus on the safety of Novartis AG's experimental gene therapy drug when it meets to review the product on Wednesday. Shares of the company are up 12% year to date.

If the drug, CTL019 (tisagenlecleucel), will be approved to market, it will be the first gene therapy marketed in the United States. The FDA is not obligated to follow the recommendations of its advisors but usually does.

CTL019 is an investigational chimeric antigen receptor T cell (CAR-T) therapy, for the treatment of adult patients with relapsed and refractory (r/r) diffuse large B-cell lymphoma (DLBCL), who have failed two or more prior therapies. The way the therapy works involves T cells being extracted from patients, genetically re-engineered, and then unleashed to kill leukemia cells.

The FDA announced Monday that the focus of the panel meeting will be on safety. As the drug has successfully met the main goal of the clinical trial, the panel will be asked only to discuss the short-term and long-term safety risks.

Earlier on April 18th, when the FDA has granted Breakthrough Therapy designation to CTL019, Vas Narasimhan, Global Head of Drug Development and Chief Medical Officer, Novartis, said, "At Novartis, we are eager to unlock the full potential of CTL019, including the potential to help patients with r/r DLBCL… We look forward to working closely with the FDA to help bring this potential new treatment option to patients as soon as possible."

About the Novartis CAR-T Program

In 2012, Novartis and the University of Pennsylvania entered into a global collaboration to further research, develop and then commercialize CAR-T cell therapies for the investigational treatment of cancers. In March 2017, Novartis announced that the US Food and Drug Administration (FDA) accepted the company's Biologics License Application filing and granted priority review for CTL019 in the treatment of relapsed/refractory (r/r) pediatric and young adult patients with B-cell acute lymphoblastic leukemia. In April 2017, FDA granted Breakthrough Therapy designation to CTL019 for relapsed/refractory diffuse large B-cell lymphoma.


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Danny Abramov



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