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A chimeric antigen receptor therapy in phase I studies for relapsed/refractory acute lymphoblastic leukemia has been granted "breakthrough therapy" status by the Food and Drug Administration, which will expedite the development and review of the product as a result, Novartis has announced.
The investigational T-cell therapy – CTL019 – is now being researched in phase I studies of pediatric and adult patients with relapsed/refractory ALL. CTL019 "uses CAR [chimeric antigen receptor] technology to reprogram a patient’s own T cells to ‘hunt’ cancer cells" that express specific proteins [CD19]. "After they have been reprogrammed, the T cells (now called CTL019) are reintroduced into the patient’s blood; they proliferate and bind to the targeted CD19+ cancer cells and destroy them," according to the statement issued by Novartis on July 7.
Researchers at the University of Pennsylvania, Philadelphia, are conducting phase I/II studies of CTL019 and are working with Novartis to study and develop CAR T-cell treatments as cancer treatments; they have submitted the filing for the breakthrough therapy status, the statement said.
If a drug is designated as breakthrough therapy, the FDA will expedite the development and review of such drug.
The breakthrough therapy designation was created by the 2012 FDA Safety and Innovation Act. The FDA defines a breakthrough therapy as a drug that is intended to treat a serious or life-threatening disease or condition, alone or in combination with other drugs, and where "preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development," according to the FDA website.
"Because of uncertainty of clinical trials, there is no guarantee that CTL019 will ever be commercially available anywhere in the world," the Novartis statement added.
A chimeric antigen receptor therapy in phase I studies for relapsed/refractory acute lymphoblastic leukemia has been granted "breakthrough therapy" status by the Food and Drug Administration, which will expedite the development and review of the product as a result, Novartis has announced.
The investigational T-cell therapy – CTL019 – is now being researched in phase I studies of pediatric and adult patients with relapsed/refractory ALL. CTL019 "uses CAR [chimeric antigen receptor] technology to reprogram a patient’s own T cells to ‘hunt’ cancer cells" that express specific proteins [CD19]. "After they have been reprogrammed, the T cells (now called CTL019) are reintroduced into the patient’s blood; they proliferate and bind to the targeted CD19+ cancer cells and destroy them," according to the statement issued by Novartis on July 7.
Researchers at the University of Pennsylvania, Philadelphia, are conducting phase I/II studies of CTL019 and are working with Novartis to study and develop CAR T-cell treatments as cancer treatments; they have submitted the filing for the breakthrough therapy status, the statement said.
If a drug is designated as breakthrough therapy, the FDA will expedite the development and review of such drug.
The breakthrough therapy designation was created by the 2012 FDA Safety and Innovation Act. The FDA defines a breakthrough therapy as a drug that is intended to treat a serious or life-threatening disease or condition, alone or in combination with other drugs, and where "preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development," according to the FDA website.
"Because of uncertainty of clinical trials, there is no guarantee that CTL019 will ever be commercially available anywhere in the world," the Novartis statement added.
A chimeric antigen receptor therapy in phase I studies for relapsed/refractory acute lymphoblastic leukemia has been granted "breakthrough therapy" status by the Food and Drug Administration, which will expedite the development and review of the product as a result, Novartis has announced.
The investigational T-cell therapy – CTL019 – is now being researched in phase I studies of pediatric and adult patients with relapsed/refractory ALL. CTL019 "uses CAR [chimeric antigen receptor] technology to reprogram a patient’s own T cells to ‘hunt’ cancer cells" that express specific proteins [CD19]. "After they have been reprogrammed, the T cells (now called CTL019) are reintroduced into the patient’s blood; they proliferate and bind to the targeted CD19+ cancer cells and destroy them," according to the statement issued by Novartis on July 7.
Researchers at the University of Pennsylvania, Philadelphia, are conducting phase I/II studies of CTL019 and are working with Novartis to study and develop CAR T-cell treatments as cancer treatments; they have submitted the filing for the breakthrough therapy status, the statement said.
If a drug is designated as breakthrough therapy, the FDA will expedite the development and review of such drug.
The breakthrough therapy designation was created by the 2012 FDA Safety and Innovation Act. The FDA defines a breakthrough therapy as a drug that is intended to treat a serious or life-threatening disease or condition, alone or in combination with other drugs, and where "preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development," according to the FDA website.
"Because of uncertainty of clinical trials, there is no guarantee that CTL019 will ever be commercially available anywhere in the world," the Novartis statement added.
