Legend Bio's CAR-T therapy clinical trial was halted by FDA

Compilenewborn

Recently, according to a report by Fierce Pharma, a foreign biopharmaceutical website, the US FDA notified Legend Bio of a clinical suspension and will provide a formal clinical suspension letter before March 11

The clinical suspension involves an early-stage CAR-T cell therapy from Legend Bio, which only started a Phase 1 clinical trial last year

Legend Bio announced the clinical suspension of LB1901 in a brief press release Tuesday morning

According to Legend Bio, the patient did not experience any serious adverse events related to the drug and is being monitored

The FDA notified the company on Friday, February 11

LB1901 is a CAR-T therapy targeting malignant CD4+ T cells for the treatment of patients with relapsed or refractory T-cell lymphoma

Legend announced the trial at the JPMorgan Chase Medical Conference in January, noting that other early-stage treatment programs are underway in China

In addition to this early-stage treatment program, Legend has a key partnership with Johnson & Johnson to work on cilta-cel, a CAR-T cell therapy for multiple myeloma, which is expected to be approved this month

cilta-cel is a BCMA-targeted chimeric antigen receptor T-cell (CAR-T) therapy for the treatment of adult patients with relapsed and/or refractory multiple myeloma (MM)

Industry analysts had previously forecast peak sales of about $2 billion for Abecma and about $500 million for cilta-cel

Reference source: Legend's early-stage CAR-T on FDA hold after single patient dosed