China Approves Its First Commercial CAR T-Cell Therapy
China recently welcomed the first CAR T-cell therapy in the country following approval from the National Medical Products Administration.
The medical regulator's green light is a milestone in the global fight against the dreaded disease, as CAR T-cell therapy has been found to be effective against specific types of late-stage blood cancer. Reports say it could cost over RMB 1 million ($154,000) for each course.
Fosun Pharma Kite Biotechnology, a joint venture of U.S. pharmaceutical giant Gilead Sciences, Inc. and Shanghai Fosun Pharmaceutical Group Co. Ltd., will soon begin marketing and sales efforts for the Gilead-made Yescarta (Axicabtagene Ciloleucel).
Yescarta is the treatment designed for adults who have been diagnosed with B-cell lymphoma and have failed to respond to two other kinds of therapy. It also applies to patients who have relapsed.
Axicabtagene Ciloleucel in this context is to be used for primary mediastinal large B-cell lymphoma, diffuse large B-cell lymphoma, high-grade B-cell lymphoma, and DLBCL from follicular lymphoma.
CAR-T cell therapy (referring to Chimeric antigen receptors) is a type of immunotherapy that utilizes modified T-cells to produce CAR on their surface. When these special cells are re-infused into a cancer patient's blood, they target specific antigens and kill tumor cells. In essence, it uses the body's own immune response to attack cancer.
CAR T-cell therapy has shown plenty of promise in combatting Non-Hodgkin's lymphoma, which is why it was approved by the U.S. Food and Drug Administration.
To date, over 300 clinical trials have been conducted in China for CAR-T cell therapy. China is second to the United States in terms of trials, accounting for 33% of global efforts. In the U.S., CAR-T therapy is used as a last-ditch effort for patients who have multiple myeloma, lymphoblastic leukemia, and lymphoma.
"In relapse or refractory LBCL, current standard-of-care is associated with poor long-term outcomes, so we are pleased to offer this new hope of survival for patients in China who are in need to new therapeutic options," said Terence O'Sullivan, Vice President, International Region at Kite, in a press release.
In China, T-cell based cancer immunotherapy is widely used in clinical settings. In 1988, doctors already started applying lymphokine-activated killer cells to tumor treatments. However, it wasn't until 2010 and 2011 that CAR T-cells entered the picture and inspired Chinese scientists to conduct domestic trials.
The news sent the Shanghai Composite index rising 0.46% to 3,573.61 points and the blue-chip CSI300 index up 0.77% on June 23.