Bristol Myers Squibb’s Breyanzi is intended to treat adult patients with relapsed or refractory large B-cell lymphoma. Credit: Nephron/ commons.wikimedia.org.

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Bristol Myers Squibb’s Breyanzi (lisocabtagene maraleucel) to treat relapsed or refractory large B-cell lymphoma (LBCL) in adult patients.

Breyanzi is intended to treat diffuse LBCL (DLBCL), high-grade B-cell lymphoma (HGBCL), primary mediastinal large B-cell lymphoma (PMBCL), and follicular lymphoma grade 3B (FL3B) in adult patients who relapsed within 12 months of completing, or are refractory to, first-line chemoimmunotherapy.

Related Company Profiles

View all

It is a CD19-directed CAR T cell therapy with a 4-1BB co-stimulatory domain which enhances the CAR T cells’ expansion and persistence.

Bristol Myers Squibb Cell Therapy Development senior vice-president Anne Kerber said: “This positive CHMP opinion is an important milestone towards introducing a potential new standard of care for people in the European Union living with relapsed or refractory large B-cell lymphoma after first-line treatment, an area of critical unmet need where few patients are able to undergo or derive long-term clinical benefit from stem cell transplant.

“We look forward to continuing to work with the European Medicines Agency, with the goal of bringing our cell therapy, Breyanzi, and the potential for cure to more people.”

See Also:

The regulator’s positive opinion was based on the data obtained from the pivotal Phase III TRANSFORM trial.

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.

The randomised, pivotal, multicentre, global trial was designed to assess Breyanzi as a second-line treatment for relapsed or refractory LBCL adult patients against the standard of care, which comprises salvage chemotherapy followed by high-dose chemotherapy and hematopoietic stem cell transplant (HSCT).

The final decision from the European Commission (EC) is expected within around two months of receipt of the CHMP opinion, and will be applicable to all EU member states, Liechtenstein, Norway and Iceland.

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