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Novel cancer treatment wins endorsement of FDA advisers

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In a unanimous decision, members of FDA's Oncologic Drugs Advisory Committee agreed to recommend an innovative cancer therapy for regulatory approval. Members accepted the CAR T-cell approach as effective, spending most of their June 12 meeting discussing strategies to handle certain safety concerns and manufacturing quality.

In a unanimous decision, members of FDA's Oncologic Drugs Advisory Committee agreed to recommend an innovative cancer therapy for regulatory approval. Members accepted the CAR T-cell approach as effective, spending most of their June 12 meeting discussing strategies to handle certain safety concerns and manufacturing quality. In the end, they determined that the benefits of the Novartis treatment outweighed the risks. If FDA follows the panel's counsel, CAR T-cell would become the first gene therapy ever approved in this country, possibly by the end of September. Hundreds were in attendance at the committee meeting, with both scientists and parents of children who underwent the treatment endorsing agency approval. CAR T-cell uses a patient's own blood to reprogram immune cells so that they attack malignant genes. A Novartis study of the technique found that 83% of participants achieved remission.

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https://www.washingtonpost.com/news/to-your-health/wp/2017/07/12/novel-cancer-treatment-wins-endorsement-of-fda-advisers/?utm_term=.9c39621376d5

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