A treatment for a common childhood blood cancer could become the first gene therapy available in the U.S.
The US Food and Drug Administration (USFDA) advisory panel has unanimously recommended that the agency approves the first gene treatment for leukemia. The company said that in its clinical trials, it was able to detect CAR-T cells in patients who respond to therapy for as long as six months, with recovery of normal B cells taking from a few months to more than one year, said Christine Cassiano, a spokeswoman for the Santa Monica, California-based company. The company is planning to maintain a patient registry to help monitor patients who receive the therapy. This new form of treatment is known as CAR-T or chimeric antigen receptor T-cell therapy.
All Novartis requires, in order to start selling the treatment, is the stamp of approval from the FDA, which it is most likely to get.
Novartis' experimental product, CTL019, is being recommended for children and young adults aged 3 to 25 who have hard-to-treat (or recurring) forms of the rare blood cancer B-cell acute lymphoblastic leukemia (ALL).
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The treatment involves drawing some blood from a patient, genetically modifying a type of immune cells call T-cells in it and re-infusing it into the patient.
The FDA is also reviewing a CAR-T from Kite Pharma for the treatment of adults with advanced and aggressive lymphoma.
The unanimous recommendation from the Oncologic Drugs Advisory Committee means the treatment could be approved by the FDA by the end of September, forging a new path in the immunotherapy frontier.
The Emily Whitehead Foundation, which raises funds for immunotherapy research, tweeted pictures on Wednesday of Emily before and after her treatment, along with a quote from her father's comments to the panel, saying the treatment killed Emily's cancer in "just 23 days". At that point, they have limited options - all more toxic than the CAR-T therapy - and survival chances are slim. At the American Association for the Advancement for Science (AAAS), researcher Stanley Riddell of the Fred Hutchinson Cancer Research Center in Washington, spoke about the miracle treatment that gives cancer patients, who have nothing to lose, hope to gain their lives back.
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First developed by the University of Pennsylvania, CTL019 uses the 4-1BB co-stimulatory domain in its vehicle to enhance cellular responses as well as persistence of CTL019 after it is infused into the patient, which may be associated with long-lasting remissions in patients. He said the treatment is "ushering in a new era".
Other companies are also pursuing CAR-T cell strategies but have struggled with major complications. "This is our first glimpse from a commercial and regulatory perspective about how the FDA is thinking about this space". 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.
In May, Novartis signaled its interest in also developing allogeneic auto T-cell therapies, when it entered a nonexclusive license agreement with Celyad to use its USA patents to produce allogeneic vehicle T cells, in a deal that could generate up to $96 million in up-front and milestone payments for the Belgian biotech.
The treatment does carry several short-term side effects, which include fever and hallucinations.
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But CAR-T's potential goes far beyond leukemia.