Novartis AG (NVS - Free Report) announced that the FDA Oncologic Drugs Advisory Committee (ODAC) has unanimously (10-0) recommended the approval of immunocellular therapy candidate CTL019 (tisagenlecleucel).
CTL019, an investigational chimeric antigen receptor T cell (CAR-T) therapy, is being evaluated for the treatment of relapsed or refractory (r/r) pediatric and young adult patients with B-cell acute lymphoblastic leukemia (ALL).
We remind investors that CTL019 was first developed by the University of Pennsylvania. Novartis entered into a collaboration agreement in 2012 with Penn to further research, develop and commercialize CAR-T cell therapies, including CTL019, for the treatment of cancers.
CAR-T is manufactured for each individual patient using their own cells thereby making it different from typical small molecule or biologic therapies. During the treatment process, T cells are drawn from a patient's blood. These cells are then reprogrammed in the manufacturing facility to create T cells that are genetically coded to express a chimeric antigen receptor to recognize and fight cancer cells and other Bcells expressing a specific antigen.
Earlier in 2017, Novartis submitted its Biologics License Application (BLA) for CTL019 to the FDA, marking the first submission by Novartis for a CAR-T cell therapy.
We remind investors that CTL019 previously received FDA Breakthrough Therapy designation. The application is under Priority Review in the U.S. While the FDA will consider the ODAC vote as it reviews the BLA, it is not obligated to follow the recommendation. A decision is expected by Oct 2017.
The recommendation was based on review of CTL019 r/r B-cell ALL development program, including the pivotal phase II global trial, ELIANA, the first pediatric global CAR-T cell therapy registration trial.
CTL019 could become the first CAR-T cell therapy if approved. A potential approval will also open new frontiers in the treatment of cancer by advancing immunocellular therapy for children and young adults with r/r B-cell ALL.
Meanwhile, Novartis plans to make additional filings for CTL019 in the EU later this year, including applications with the FDA and European Medicines Agency (EMA) for the treatment of adults with r/r diffuse large B-cell lymphoma (DLBCL).
Novartis has outperformed the Zacks classified industry in the last six months. The stock has rallied 13.0% compared with the Large Cap Pharmaceuticals industry’s 11.3% gain.
Going forward, we expect that the approval of new drugs and label expansion of existing ones will bode well for Novartis. Also, strong performance of growth products should be able to offset the impact of generic competition for Gleevec.
The news bode well for other companies who are developing CAR-T cell therapies like Kite Pharma Inc. (KITE - Free Report) . The company submitted its BLA to the FDA in Mar2017 for the approval of lead candidate KTE-C19. KTE-C19 is a CAR-based therapy, being evaluated for the treatment for patients with relapsed or refractory aggressive B-cell non-Hodgkin lymphoma and DLBCL. The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of Nov 29.
Meanwhile, bluebird bio (BLUE - Free Report) and Celgene Corp. (CELG - Free Report) also entered into a collaboration to develop CAR-T cell therapies for cancer. The collaboration was amended and restated to focus on developing product candidates targeting B-cell maturation antigen (BCMA).
Novartis currently carries a Zacks Rank #3 (Hold).
You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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