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FDA Panel Recommends Approval for Gene-Altering Leukemia Treatment

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The Oncologic Drugs Advisory Committee unanimously recommended approval of a first-of-its-kind cancer treatment that uses patients’ revved-up immune cells to fight acute lymphocytic leukemia (ALL) which means the treatment could be approved by the FDA by the end of September.

Novartis, the drugmaker behind the CAR T-cell therapy, 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. But the approach also is being tested for a range of hematologic cancers.

This could very well be the beginning of a new era in the management of cancer.

As with any new and powerful scientific tool, the successes have been spectacular and the failures horrific.

Approval for chronic lymphocytic leukemia (CLL) will be a few years behind, but it is definitely near the front of the line.

I see it coming as the technology get stronger and we better understand the toxicities, especially the potentially deadly neurotoxicities, and all the other risks and failures.

Still lots of work ahead, but exciting times.

This could be the future- One shot (or two) and cancer free forever.

Read more here:

NY Times

Washington Post