The review date of Legendary Bio's BCMA CAR-T cell therapy was postponed by the U.S. FDA for 3 months

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Recently, the BCMA CAR-T cell therapy ciltacabtagene autoleucel (cilta-cel), jointly developed by Nanjing Legend Biotechnology and Johnson & Johnson’s Johnson Biotechnology, has encountered setbacks in the US supervision: FDA has extended the review timeline of cilta-cel by 3 Month

This is somewhat surprising.

The FDA postponed the review of cilta-cel because the agency has some questions about this CAR-T therapy, which will take time to resolve

Why postponed? The reason is somewhat vague

Nanjing Legend and Yang Sen met with the FDA on November 1

The marketing application of cilta-cel is based on an open-label Phase 1b/2 study, which enrolled patients with relapsed and/or refractory multiple myeloma (MM) who had previously tried 3 treatments

These data have attracted the attention of many MM experts

In March of this year, the BCMA CAR-T cell therapy Abecma from Bristol-Myers Squibb and Bluebird was approved by the US FDA, becoming the world's first BCMA CAR-T cell therapy to receive regulatory approval

Affected by the unfavorable news about cilta-cel supervision, the share price of Nanjing Legend fell nearly 9% in pre-market trading on the Nasdaq stock market on Tuesday morning

Reference source: Legend's status put on hold as FDA delays Janssen-partnered CAR-T decision