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Novartis' CTL109 BLA Gets Priority Review Status from FDA
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Novartis A.G. (NVS - Free Report) announced that the FDA has accepted and granted priority review designation to its biologics license application (BLA) for pipeline candidate, CTL019 (tisagenlecleucel-T). The company plans to apply for market authorization with European Medicines Agency later this year.
Novartis is evaluating CTL019, an experimental chimeric antigen receptor T cell (CAR-T) therapy, for the treatment of pediatric and adult patients suffering from relapsed/refractory acute lymphoblastic leukemia (r/r ALL).
A look at Novartis’ share price movement over the past one year shows that the stock has underperformed the Zacks classified Large Cap Pharma industry. Specifically, Novartis’ stock gained 3.3% during this period, while the industry gained 6.6%.
CAR-T is a novel therapy as it is personalized for each individual patient. It reprograms a patient's own T cells to look for cancer cells and other B-cells expressing a particular antigen, called CD19. Once reprogrammed, the T cells (called CTL019 after reprogramming) are released into the patient's blood so as to proliferate and bind to the targeted CD19+ cancer cells and destroy them.
CTL019 was first developed by the University of Pennsylvania. In 2012, the university signed an exclusive global agreement with Novartis to research, develop and commercialize personalized CAR-T cell therapies for the treatment of cancers.
The new drug application for CTL019 was submitted to the FDA based on a phase II CAR-T cell study, Eliana. Data from the study showed that of the patients infused with CAR-T cells, 82% achieved complete remission or complete remission with incomplete blood count recovery after three months of CTL019 infusion. The data were presented at the American Society of Hematology meeting in Dec 2016. We note that the priority review designation from the FDA should shorten the anticipated review time.
The investigational therapy had previously received Breakthrough Therapy designation from the FDA for the treatment of patients with r/r ALL. Novartis is planning to file a BLA with the FDA and a marketing authorization with EMA for CTL019 for treatment of adults with r/r diffuse large B-cell lymphoma (DLBCL).
We remind investors that Kite Pharma, Inc. has also filed a BLA for its CAR-T candidate, KTE-C19 for treatment DLBCL in December last year.
Novartis has collaborated with Intellia Therapeutics Inc. (NTLA - Free Report) for the discovery and development of treatments using CAR-T with the latter’s CRISPR genome editing technology. Juno Therapeutics Inc. is also using CRISPR to better its CAR-T and TCR platforms.
Novartis currently carries a Zacks Rank #4 (Sell).
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Novartis' CTL109 BLA Gets Priority Review Status from FDA
Novartis A.G. (NVS - Free Report) announced that the FDA has accepted and granted priority review designation to its biologics license application (BLA) for pipeline candidate, CTL019 (tisagenlecleucel-T). The company plans to apply for market authorization with European Medicines Agency later this year.
Novartis is evaluating CTL019, an experimental chimeric antigen receptor T cell (CAR-T) therapy, for the treatment of pediatric and adult patients suffering from relapsed/refractory acute lymphoblastic leukemia (r/r ALL).
A look at Novartis’ share price movement over the past one year shows that the stock has underperformed the Zacks classified Large Cap Pharma industry. Specifically, Novartis’ stock gained 3.3% during this period, while the industry gained 6.6%.
CAR-T is a novel therapy as it is personalized for each individual patient. It reprograms a patient's own T cells to look for cancer cells and other B-cells expressing a particular antigen, called CD19. Once reprogrammed, the T cells (called CTL019 after reprogramming) are released into the patient's blood so as to proliferate and bind to the targeted CD19+ cancer cells and destroy them.
CTL019 was first developed by the University of Pennsylvania. In 2012, the university signed an exclusive global agreement with Novartis to research, develop and commercialize personalized CAR-T cell therapies for the treatment of cancers.
The new drug application for CTL019 was submitted to the FDA based on a phase II CAR-T cell study, Eliana. Data from the study showed that of the patients infused with CAR-T cells, 82% achieved complete remission or complete remission with incomplete blood count recovery after three months of CTL019 infusion. The data were presented at the American Society of Hematology meeting in Dec 2016. We note that the priority review designation from the FDA should shorten the anticipated review time.
The investigational therapy had previously received Breakthrough Therapy designation from the FDA for the treatment of patients with r/r ALL. Novartis is planning to file a BLA with the FDA and a marketing authorization with EMA for CTL019 for treatment of adults with r/r diffuse large B-cell lymphoma (DLBCL).
We remind investors that Kite Pharma, Inc. has also filed a BLA for its CAR-T candidate, KTE-C19 for treatment DLBCL in December last year.
Novartis has collaborated with Intellia Therapeutics Inc. (NTLA - Free Report) for the discovery and development of treatments using CAR-T with the latter’s CRISPR genome editing technology. Juno Therapeutics Inc. is also using CRISPR to better its CAR-T and TCR platforms.
Novartis currently carries a Zacks Rank #4 (Sell).
You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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Today, you are invited to download the full list of 220 Zacks Rank #1 "Strong Buy" stocks – absolutely free of charge. Since 1988, Zacks Rank #1 stocks have nearly tripled the market, with average gains of +26% per year. Plus, you can access the list of portfolio-killing Zacks Rank #5 "Strong Sells" and other private research. See these stocks free >>