Can data from one CAR T-cell therapy be used to inform FDA’s review of other CAR T products?
FDA has approved MI Cancer Seek for use as a companion diagnostic to identify patients with cancer who may benefit from treatment with targeted therapies.
Industry, FDA, Friends focus on data needed to speed up development of gene and cell therapies
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FDA’s cancer czar Richard Pazdur had a “silver anniversary” at the agency recently. So, he invited some guests—the commissioners he had reported to under the Democratic and Republican administrations.
Scemblix (asciminib) was granted accelerated approval by FDA for adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase.
Thomas Bradley has been appointed director of hematology and oncology at Staten Island University Hospital’s Florina Cancer Center to spearhead the division’s clinical, educational, and research initiatives.
FDA in collaboration with U.S. Customs and Border Protection, announced the administrative seizure of approximately three million units of unauthorized e-cigarette products, with an estimated retail value of $76 million.
FDA has approved Vyloy (zolbetuximab-clzb), a claudin 18.2-directed cytolytic antibody, with fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of adults with locally advanced unresectable or metastatic human epidermal growth factor receptor 2-negative gastric or gastroesophageal junction adenocarcinoma whose tumors are CLDN18.2 positive, as determined by an FDA-approved test.
