美国监管机构批准白血病基因疗法
US regulators on Wednesday approved the first gene therapy against cancer - a treatment that uses a patient's own immune cells to fight leukemia - opening a new era in the fight against one of the world's top killers.
美国监管机构于8月30日批准了首个对抗癌症的基因治疗手段——使用患者的免疫细胞对抗白血病。白血病是世界上致死率最高的疾病之一，该治疗手段开启了对抗白血病的新纪元。
The treatment is made by Novartis and is called Kymriah.
This type of anti-cancer immunotherapy, known as a CAR-T cell therapy, was known by CTL019 until now.
"This marks the first-ever CAR-T cell therapy to be approved anywhere in the world," Novartis CEO Joseph Jimenez told reporters on a conference call.
"It uses a new approach that is wholly personalized by using a patient's own T-cells."
Kymriah was approved by the US Food and Drug Administration for children and young adult patients up to age 25 with a form of acute lymphoblastic leukemia (ALL).
To qualify for treatment, patients must have B-cell precursor ALL that is refractory, or the patient has relapsed at least twice.
The FDA described the approval as "a historic action" and a "new approach to the treatment of cancer and other serious and life-threatening diseases," said a statement.