US regulators have approved Kite Pharma’s blood cancer treatment Yescarta (axicabtagene ciloleucel), and the chimeric antigen receptor T cell (CAR-T) therapy will hit the market with a $373,000 price per course.
Yescarta’s go-ahead comes as a big win for Kite and its new owner Gilead Sciences. as the treatment becomes the first CAR-T therapy approved to treat adults with relapsed or refractory B-cell lymphoma after two or more lines of systemic therapy.
John Milligan, president and chief executive officer of Gilead Sciences, said: “It’s an important day for patients with relapsed or refractory large B-cell lymphoma who have run out of options and have been waiting for new treatments that may help them in their fight against cancer.
“With the combined innovation, talent and drive of the Kite and Gilead teams, we will rapidly advance cell therapy research and aim to bring new options to patients with many other types of cancer.”
According to the pharma group, diffuse large B-cell lymphoma (DLBCL) is the most common form of aggressive non-Hodgkin lymphoma (NHL), accounting for three out of every five cases with approximately 7,500 US patients eligible for CAR-T therapy.
Arie Bellergrun, Kite’s founder, said: “The FDA approval of Yescarta is a landmark for patients with relapsed or refractory large B-cell lymphoma.
“We must also recognise the FDA for their ability to embrace and support transformational new technologies that treat life-threatening illnesses.”
The regulator’s decision was based on date from the ZUMA-1 trial, in which 72% of patients treated with a single infusion of Yescarta responded to therapy including 51% of patients who had no detectable cancer remaining.
However, the drug will have to carry a boxed warning, advising patients of potential neurologic toxicities and cytokine release syndrome (CRS), the latter of which can cause low blood pressure, seizures and hallucinations.
The treatment is currently under review with the European Medicines Agency (EMA) with potential approval in Europe expected in the first half of 2018.