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Recommendation for Novartis May Give New Hope For Some Cancer Patients

In a milestone decision, an FDA advisory panel Wednesday recommended that the Food and Drug Administration greenlight an immunotherapy to treat some blood cancer patients.

The panel voted 10-0 to recommend Novartis (NVS) CAR-T therapy CTL109 for children and young adults with advanced leukemia. Though the treatment has posted excellent results among patients where traditional treatment paths have failed, CAR-T has been considered an experimental treatment. The Novartis drug is the first CAR-T to be reviewed by the regulator and this and other CAR-T therapies are likely to change the way serious blood cancers are treated.

The committee decision now gets passed to the FDA which is expected to render a final decision regarding CTL109 by Oct.3. Advisory panel recommendations are not binding on the FDA but the agency typically adheres to what the group urges.

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Novartis shares were up $1.21, or 1.48%, Wednesday to close at $83.21. But after-hours trading continued to push them upward. Two hours after the market closed they were up another 1.43% to $84.40.

"I don't think it is an embellishment to say this is a historic day," said veteran biotech investor Brad Loncar, who was at the FDA hearing. "This is an entirely new way of treating cancer and I think these cellular therapies are only in their first chapter."

The treatments involve extracting white blood cells or T-cells which defend the immune system, from cancer patients. The cells would be frozen and sent to Novartis's facility, where they would be engineered to hunt for a protein marker called CD19 found in some blood cancers. The cells would be altered to seek out the cancer and attack it. The cells would then be refrozen and sent back to the patient...