U.S. approves second gene therapy for blood cancer
21 October, 2017, 00:46 | Author: Regina Lloyd
The T cells are filtered from a patient's blood, reprogrammed to target and kill cancer cells, and then hundreds of millions of copies are grown and returned to the patient to fight the disease. There are approximately 72,000 new cases of National Hockey League diagnosed in the United States annually. The FDA has approved a risk evaluation and mitigation strategy (REMS) for Yescarta that will inform and educate health care professionals about its associated risks.
Noting the FDA's commitment to "supporting and helping expedite" the development of gene therapies, Gottlieb said, "we will soon release a comprehensive policy to address how we plan to support the development of cell-based regenerative medicine". It's the second time the FDA has approved a gene therapy for use in the United States following a procedure meant to treat leukemia earlier this year. The FDA warns that axicabtagene ciloleucel has a boxed warning for cytokine release syndrome, which causes a high fever, flu symptoms, and neurological toxicities.
While a $373,000 start price target sounds off the charts, Yescarta is actually cheaper than a rival auto T treatment from Novartis at $475,000.
"We are in ongoing and active discussions with payers, and we have communicated our openness to considering different solutions that improve patient access", Gilead spokeswoman Amy Flood said in an email. Yescarta (axicabtagene ciloleucel) has been approved by the U.S. Food and Drug Administration for individuals with certain types of large B-cell lymphoma who have not responded to or who have relapsed after at least two other kinds of treatment.
The highly personalized cancer treatment is a type of vehicle T-cell therapy (CAR is short for chimeric antigen receptor).
All patients had chemorefractory disease and had received a median of 3 prior lines of therapy, with 54% refractory to 2 consecutive lines of therapy.
"The acquisition of Kite establishes Gilead as a leader in cellular therapy and provides a foundation from which to drive continued innovation for people with advanced cancers", GILD CEO, John F. Milligan, Ph.D., said in a statement. Other side effects include infections, low blood cell counts, and dampened immune system. Using the patient's immune system to attack cancer cells can be very effective for treating malignancies and keeping cancer in remission, she noted.
"Today's approval of Yescarta is a very significant advance for lymphoma patients and for the cancer community as a whole", Louis J. DeGennaro, president of the Leukemia & Lymphoma Society, said in a statement. "Engineered cell therapies like Yescarta represent the potential for a changing treatment paradigm for cancer patients", said David Chang, MD, PhD, worldwide head of Research and Development and Chief Medical Officer at Kite Pharma.
Yescarta was initially developed by researchers at the National Cancer Institute in Washington, DC. However, the treatment is also known to trigger life-threatening side effects.
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