Express | Janssen/Legendary Bio-CAR-T Therapy Completes Rolling Submission of FDA Biological Products License Application

▎The content team editor of WuXi AppTec recently stated in a regulatory document submitted to the U.
S.
SEC that the company’s partner, Janssen, has completed a rolling submission to the U.
S.
FDA for targeting B-cell maturation antigen (BCMA).
CAR-T therapy ciltacabtagene autoleucel (cilta-cel) biological product license application (BLA) for the treatment of adult patients with relapsed/refractory multiple myeloma.

Since this innovative CAR-T therapy was granted a breakthrough therapy designation by the U.
S.
FDA in 2019, its BLA is expected to receive priority review and may be approved by the FDA before the end of this year.

Multiple myeloma (MM) is an incurable blood cancer caused by canceration of white blood cells called plasma cells.

Cancerous plasma cells spread rapidly in the bone marrow and replace normal cells in the bone marrow.

Although some patients with multiple myeloma have no symptoms, most diagnosed patients’ symptoms may include fractures or pain, low red blood cell counts, fatigue, high calcium levels, kidney problems, or infections.

Although there are many treatments for MM, most patients will still relapse after remission.

Cilta-cel is a CAR-T cell therapy with a differential structure.
It contains a 4-1BB costimulatory domain and two antibody domains targeting BCMA.
It has the ability to promote the expansion of CD8-positive T cells.

BCMA is a protein highly expressed on myeloma cells.

In December 2017, Janssen Biotechnology Co.
, Ltd.
reached a global exclusive license and cooperation agreement with Legend Bio to jointly develop and commercialize cilta-cel. ▲The structure diagram of Cilta-cel (also known as JNJ-4528/LCAR-B38M) (picture source: Legend Biology official website) The latest clinical data released at the annual meeting of the American Society of Hematology held last year showed that cilta-cel was named CARTITUDE-1's Phase 1b/2 clinical trial continued to show a very high overall response rate (ORR).
At a median follow-up time of 12.
4 months, the ORR reached 97%, and the patient's remission over time The degree further deepened, and 67% of patients reached a strict complete remission.

When the median follow-up time was 12.
4 months, the patient's median duration of remission and progression-free survival had not yet been reached.

A few days ago, Abecma (idecabtagene vicleucel), jointly developed by Bristol-Myers Squibb (BMS) and bluebird bio, was approved by the FDA and became the first cell therapy targeting BCMA.

Janssen/Legendary's cilta-cel is expected to become the second approved cell therapy targeting BCMA this year, bringing more treatment options to patients with multiple myeloma.

Reference: [1] Form 20-F, Legend Biotech Corporation, Retrieved April 5, 2021, from Note: This article It is intended to introduce the progress of medical and health research, not to recommend treatment options.

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