FDA Approves 2nd Cancer Treatment Using Gene Therapy for Non-Hodgkins Lymphomas

FDA Approves 2nd Cancer Treatment Using Gene Therapy for Non-Hodgkins Lymphomas

US regulators on Wednesday approved a second gene therapy for a blood cancer, a one-time, custom-made treatment for aggressive lymphoma in adults. It represents a breakthrough in hematologic cancer treatment in which a patient's own T cells are engineered to seek and destroy cancer cells. These are then sent to a facility in El Segunda, California - which Kite opened in June previous year - where they are stimulated to proliferate and transduced with a retroviral vector to introduce the vehicle sequence into the patient's T cells before being propagated in cell culture bags. "These are going away within 1 month of the therapy, so we think that this is a therapy that can be safely administered across multiple centers for patients who are really without other treatment options".

The price of Yescarta is set below that of comparable treatments, according to Reuters, as Novartis AG's gene therapy costs $475,000. 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.

"Both CRS and neurologic toxicities can be fatal or life-threatening", the FDA warned.

This approval marks the second gene therapy to be approved by FDA and the first to be approved for certain types of non-Hodgkin lymphoma.

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"It is important to note that the toxicities that we saw-CRS and neurological events-are generally reversible", lead investigator Frederick L. Locke, MD, medical oncologist at Moffitt Cancer Center, told Oncology Nursing News at the 2017 AACR Annual Meeting.

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 safety and efficiency of Yescarta were established in a multicenter clinical trial of more than 100 adults with refractory or relapsed large B-cell lymphoma, the FDA said. "In just several decades, gene therapy has gone from being a promising concept to a practical solution to deadly and largely untreatable forms of cancer", said FDA Commissioner Scott Gottlieb, MD.

"Other side effects include serious infections, low blood cell counts and a weakened immune system".

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For more on what role pharmacists can play for patients with lymphoma, view the video below.

"We believe this is only the beginning for CAR-T therapies", said Belldegrun in a statement. "We remain committed to supporting the efficient development of safe and effective treatments that leverage these new scientific platforms". In the United States alone, there are approximately 7,500 patients each year with refractory diffuse large B-cell lymphoma who are said to be eligible for auto T therapy.

Almgren said the approval of Yescarta is "certainly very exciting". Each dose of Yescarta is customized based on a patient's immune system to help fight the immune system.

The FDA decision opens the door for a new gene therapy to treat adults with aggressive lymphoma, noted Maloney.

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