US FDA approves Gilead cell therapy for earlier lymphoma

The US Food and Drug Administration (FDA) recently approved expanded use of Yescarta, a cell therapy made by Gilead Sciences Inc’s Kite unit, as the first option after chemotherapy for adults with an advanced, aggressive form of blood cancer.

The one-time treatment was initially approved in 2017 for patients with large B-cell lymphoma who did not respond to at least two previous rounds of therapy.

Yescarta is part of a class of treatments known as CAR-Ts, which involve taking immune system blood cells from a patient, shipping them to a plant to be re-engineered to better fight certain cancers and then returning them to the patient.

Kite’s trial results showed that Yescarta improved the length of time patients stayed alive without serious complications by 60 per cent over chemotherapy and stem cell transplant in second-line large B-cell lymphoma.

The National Comprehensive Cancer Network, the most influential source of US oncology treatment guidelines, has already listed Yescarta in the first category of treatments for those patients.

The FDA said the drug’s label warns of a serious complication associated with CAR-T therapy called cytokine release syndrome, which can cause a range of dangerous symptoms including fever and neurological problems.

Edits  by EP News Bureau