NOVEL CANCER TREATMENT WINS FDA ENDORSEMENT
Food and Drug Administration advisers on Wednesday enthusiastically endorsed a first-of-its-kind cancer treatment that uses patients’ revved-up immune cells to fight the disease, concluding that the therapy’s benefits for desperately ill children far outweigh its potentially dangerous side effects.
The unanimous recommendation from the Oncologic Drugs Advisory Committee means the treatment could be approved by the FDA by the end of September.
Drugmaker Novartis is seeking approval to use it for children and young adults whose leukemia doesn’t respond to traditional treatments — a group that numbers 600 or so patients a year in this country. The approach also is being tested for a range of diseases, from non-Hodgkin lymphoma and multiple myeloma to solid tumors.
If cleared by the FDA, it would be the first gene therapy approved in the United States. But unlike traditional gene therapy, the new treatment doesn’t replace diseasecausing genes with healthy ones. Instead, it uses technology to reprogram immune cells called T cells to target and attack malignancies. — The Washington Post