Sunday, July 16, 2017
=Novartis (NVS) secures FDA panel's approval for cancer drug
Swiss pharmaceutical company Novartis AG's ( NVS) new cancer drug on Wednesday won the backing of a Food and Drug Administration advisory panel, Reuters reports.
The panel's decision paves the way for the first gene therapy to be approved in the U.S.
The panel voted 10-0 that the drug, tisagenlecleucel, should be approved to treat patients with relapsed B-cell acute lymphoblastic leukemia (ALL), the most common form of U.S. childhood cancer.
The FDA is not required to follow the panel's recommendations, but it typically does so. The FDA is expected to rule on the drug by the end of September.
Labels:
cancer,
FDA approval,
gene therapies,
leukemia,
Novartis (NVS),
tisagenlecleucel
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