Gilead's Lymphoma Drug Gets Approved

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The product is made by isolating peripheral blood mononuclear cells, including T-cells, from the patient's own white blood cells.

Adults with relapsed or refractory non-Hodgkin lymphoma (NHL) now have new hope. "Together, Gilead and Kite will accelerate studies of CAR-T therapy in multiple blood cancers and advance other cell therapy approaches for solid tumors, with the goal of helping patients with diverse cancers benefit from this new era of personalized cancer therapy".

Non-Hodgkin lymphomas account for roughly four percent of all cancers in the United States and an estimated 72,000 new cases are diagnosed each year, CNN said. The FDA has approved Gilead's vehicle T lymphoma treatment named Yescarta.

In a clinical trial of more than 100 adults, 51% of patients treated with Yescarta achieved complete remission, far higher than what is normal with present standard-of-care treatments.

The adverse effect profile remains the same for this treatment as for tisagenlecleucel-the drug has a boxed warning for cytokine release syndrome and for neurologic toxicities, which can both be fatal or life-threatening.

Gilead has listed axicabtagene ciloleucel at $373,000 in the United States, much cheaper than the launch price of tisagenlecleucel at $475,000. CAR-T therapy is customized for each patient. "That policy will also clarify how we will apply our expedited programs to breakthrough products that use CAR-T cells and other gene therapies".

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Gilead shares stand at US$80.01 in NY. "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", FDA commissioner Dr. Scott Gottlieb said. Food and Drug Administration approved a new form of cell-based gene therapy for adults with certain types of large B-cell lymphoma, marking only the second time a gene therapy has been approved for the disease.

Because of these risks, FDA is requiring hospitals and associated clinics that dispense the treatment to be specially certified, including training to recognize and manage CRS and nervous system toxicities.

Other potential side effects include serious infections and a weakened immune system. "This approval would not have been possible without the courageous commitment of patients and clinicians, as well as the ongoing dedication of Kite's employees". Because not everybody with these advanced forms of cancer respond to the treatment, if patients don't respond to Kymriah within a month, the patient doesn't have to pay for it. Yescarta did not make the same arrangement.

"We believe this is only the beginning for CAR-T therapies", said Belldegrun in a statement.

Dr. David Maloney, medical director of cellular immunotherapy at Fred Hutchinson Cancer Research Center, helped develop the therapy and said the FDA's second approval of a CAR-T cell therapy "validates the revolution underway in the field of cellular immunotherapy".

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