Share
Myeloma cells produce monoclonal proteins of varying types. Credit: www.scientificanimations.com / Wikimedia.

Bristol-Myers Squibb has received approval from Japan’s Ministry of Health, Labour and Welfare for its therapy Abecma (idecabtagene vicleucel) to treat relapsed or refractory (R/R) multiple myeloma in adults, according to an announcement.

Abecma is a chimeric antigen receptor (CAR) T cell immunotherapy directed by B-cell maturation antigen (BCMA).

Related Company Profiles

View all

In March last year, the company’s CD19-directed genetically modified autologous T cell immunotherapy Breyanzi received approval.

With the latest approval, Bristol Myers Squibb now has two approved CAR T cell therapies.

The Ministry’s approval is based on safety and efficacy data obtained from the international Phase II Study BB2121-MM-001 and the Phase I Study CRB-401 conducted in the US.

The Phase II study was conducted in Japan, the EU, the US and Canada.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

Bristol-Myers Squibb president and CEO Jean-Christophe Barland said: “Abecma delivers a new treatment option for patients with multiple myeloma, the first option directed against BCMA and using a new mode of action.

“This approval is a testament to our strong commitment to addressing unmet medical needs for patients in Japan. As a game-changer committed to ‘innovation with heart,’ Bristol Myers Squibb Japan will continue its efforts to help patients prevail over serious diseases.”

The personalised immune cell therapy Abecma, which received approval as a one-time infusion, identifies and attaches to the BCMA protein as an anti-BCMA CAR T cell therapy.

BCMA is universally expressed on multiple myeloma cancer cells and results in their death.

Till now, multiple myeloma has no approved therapeutic options in Japan.

Last August, the European Commission granted conditional marketing authorisation to Bristol Myers Squibb’s Abecma to treat relapsed and refractory multiple myeloma in adult patients.

Cell & Gene Therapy Coverage on Pharmaceutical Technology supported by Cytiva.

Editorial content is independently produced and follows the highest standards of journalistic integrity. Topic sponsors are not involved in the creation of editorial content.