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The European Medicines Agency's (CHMP) Human Medicines Board (CHMP) will accelerate the evaluation of the listing license application (MAA) for the CAR-T therapy Cilta-cel, the company announced today.
Cilta-cel is a CAR-T therapy targeted at BCMA.
Cilta-cel is being developed to treat patients with relapsed multiple myeloma (MM).
CAR-T therapy is a highly personalized technology that reprograms the patient's own T-cells to treat cancer.
, a rare and incurable cancer, has long been an area of concern for Johnson and Johnson," said Sen Zhuang, vice president of clinical research and development at Johnson and Johnson Pharmaceuticals.
we are firmly committed to improving the prognosis of patients with multiple myeloma."
approval of the IB/II CARTITUDE-1 clinical study is supported by positive results.
multiple myeloma (MM) is an incurable blood cancer that begins in the bone marrow and is characterized by excessive proliferation of plasma cells.
, more than 48,200 people were diagnosed with MM in 2018.
about 50 percent of first-time patients do not reach five-year survival, and almost 29 percent of multiple myeloma patients die within one year of diagnosis.
