J&J, Legend’s Cell Therapy Gets FDA Nod

The FDA has given approval to cilta-cel, a CAR T-cell therapy developed by Legend Biotech and Johnson & Johnson, to treat multiple myeloma. The cell therapy, which will be sold as Carvykti, is the second approved BCMA CAR T-cell therapy, after bluebird’s Abecma. It is also China-based Legend’s first approved product in the US market.

The nod comes as drug regulators are increasing their scrutiny of clinical trials held in China. Two weeks ago, an FDA panel rejected Eli Lilly and Inovent’s immunotherapy, on the grounds that their drug was only tested in China. In Legend and J&J’s case, clinical trials of cilta-cel were initially conducted in China, and then in the US and Japan. 

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Results from Cartitude-1 Study in Multiple Myeloma

Like Abecma, cilta-cel selectively targets BCMA, a protein that is highly expressed in malignant plasma cells. Cilta-cel got the attention of J&J after Legend reported at ASCO 2017 that the therapy elicited a 100% overall response rate in multiple myeloma patients. J&J eventually reached out to Legend, paying $350 million upfront to partner over cilta-cel. 

The approval of cilta-cel was based on the Cartitude-1 study which tested the therapy in 100 patients with multiple myeloma. The results showed that 83% of patients achieved a “stringent complete response”, where the cancer cannot be detected in the blood or bone marrow, at a median follow-up of 22 months. 

The follow-up also revealed that 74% of treated patients were still alive and 61% did not have further disease progression. 

J&J has set the price tag of Carvykti at $465,000, but said they expect the majority of costs to be covered by commercial insurers and Medicare. The pharma giant has projected peak annual sales of Carvykti exceeding $5 billion. 

Based on a deal struck in 2017, J&J and Legend will split the profits 30-70 in China and 50-50 in all other countries. Cilta-cel is currently under review in Europe and Japan, while Legend has yet to file an application for drug approval in China. 

Related Article: Bristol-Myers Squibb’s Abecma Becomes First Approved CAR T-Cell Therapy for Multiple Myeloma in Japan

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Joy Lin

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