The United States has approved the first CAR-T cell therapy for patients with bone marrow cancer

The FDA’s approval is based on the central phase 2 study KarMMa which included 128 patients. The patients in the study received one of three dosage levels ranging from 150 to 450 million T cells. The majority of patients achieved a “quick, deep and sustained response”, Bristol Myers Squibb and Bluebird Bio state in a press release. The response rate was 73%, including a complete response rate of 33%. The median response time was 11 months. The patients lived a median of almost nine months without the disease worsening – a measure called progression-free survival. The patients treated in the study with the highest dose had a response rate of 82%, including a complete response rate of 39%. These patients lived a median of one year without the disease worsening.

One patient in the study died of a severe case of cytokine storm, an immune reaction often associated with CAR-T treatment. Overall, moderate to severe cytokine storms were reported in less than 6% of patients. Three percent of patients reported high-grade neurotoxicity, another side effect often seen in CAR-T therapy.

The study was published in the New England Journal of Medicine in February.

– CAR-T cell therapies have shown a groundbreaking potential for the treatment of blood cancer. We are proud to be able to offer the first CAR-T cell therapy to multiple myeloma patients who have undergone several treatment lines, which provides the opportunity for long-term effect, says Samit Hirawat who is Bristol Myers Squibb’s chief physician.

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