US FDA recommends new genetic treatment to fight cancer

US FDA recommends new genetic treatment to fight cancer

US FDA recommends new genetic treatment to fight cancer

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 FDA is not required to follow the recommendations of its advisers but typically does so.

"This is a major advance and is ushering in a new era", said committee member Malcolm A Smith, who is associate branch chief for paediatric oncology at the National Cancer Institute in Bethesda, Maryland.

However, Connor underwent the new treatment at Duke University and has since recovered so well that he is back to playing hockey, his father said. Novartis is seeking approval to use the therapy on patients ages three to 25, particularly in patients who have failed to respond to standard treatments - something that occurs in over 600 people in the United States yearly. ALL is the most common type of cancer in children, with clinicians diagnosing about 3,000 cases in Americans below the age of 20 each year.

Makers of immunoglobulin are reluctant to talk about the issue, since their products aren't approved for patients who develop secondary immune deficiencies that are a complication of another medical condition or treatment. For Emily and many other patients participating in the Novartis trials, the auto T therapy was an alternative, rather than just a bridge, to a bone marrow transplant, which carries a 30 percent survival rate.

Bryan noted at the outset of the meeting, that it's still not clear how FDA or Novartis can assure patients that the marketed product would be the same product as what was studied in clinical trials, though Novartis will monitor patients for 15 years after treatment.

This therapy is a one-time treatment for children and young adults affected by the most common form of childhood cancer, acute lymphoblastic leukemia or ALL. That happens to more than 600 patients in the USA each year. Connor, now 16, is one of CAR-T's success stories.

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In drug trials, the immunotherapy results worked far better than chemotherapy and newer types of cancer drugs. As such, he has studied and treated patients with tisagenlecleucel for over five years and receives research support from Novartis. Eleven patients died, four from side effects and seven from their leukemia.

"It's a pretty awesome new treatment", Dr. David Agus, director of the USC Norris Westside Cancer Center and CBS News medical contributor, said on "CBS This Morning".

On the safety side, the panelists delved into the possible risks of injecting genetically modified cells into patients, including the potential for deadly viral infections, brain toxicity, and, paradoxically, the growth of new tumors brought about by CAR-T cells years after treatment.

CAR-T therapies also present a gnarly regulatory challenge for the FDA: how do you assure the potency and purity of a complex, living drug that must be made fresh for each patient?

Insurance companies said their decision to cover Novartis's treatment and any follow-up therapy will be based on the clinical results of the drug. The panel recommended 10 - 0 that the treatment should be approved by the FDA. Some estimates have put the treatment costs of CAR-T therapies in the hundreds of thousands of dollars. About 85% are cured by chemotherapy, but those whose cancer returns have few options. The drug would only be used, however, if the disease failed to respond to standard treatment.

The University of Pennsylvania (Penn) has first developed CTL019, which uses the 4-1BB costimulatory domain in its chimeric antigen receptor to enhance cellular responses.

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