Novartis Tests Global Manufacturing Process For CAR-T Therapy
Rather than wait for regulatory approval prior to commercial-scale manufacturing, Novartis is proving out its global commercial manufacturing process for a CAR-T cell therapy in a Phase II clinical trial as questions remain on how to translate the manufacturing process from the research laboratory to the factory.
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CAR-T Therapies: Failure To Meet Release Specifications May Not Bar Patient Use
Some patients in Novartis' pediatric leukemia pivotal trial for tisagenlecleucel (CTL019) received out-of-spec product following the sponsor's consultation with US FDA, and the same thing might occur in the commercial setting.
Argos Nears Phase III Results For Precision Cancer Immunotherapy
With pivotal data expected in 2017 in metastatic kidney cancer, Argos hopes its drug will bridge the hot points of immuno-oncology and personalized medicine with a drug that extract’s RNA from a patient’s tumor and primes the dendritic cells to teach the immune system how to kill the cancer.
New Interim CAR-T Data Support Kite’s BLA Submission Plans
Kite Pharma Inc. executives reiterated plans on Sept. 26 to pursue US FDA approval this year for the chimeric antigen receptor T cell (CAR-T) therapy known as KTE-C19, keeping the company on track to seek accelerated approval for a form of advanced lymphoma before any of its competitors.