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Home Bristol Myers Squibb Receives Positive CHMP Opinion for CD19 CAR-T Therapy Breyanzi (lisocabtagene maraleucel) in Relapsed or Refractory DLBCL, PMBCL, and FL3B

Bristol Myers Squibb Receives Positive CHMP Opinion for CD19 CAR-T Therapy Breyanzi (lisocabtagene maraleucel) in Relapsed or Refractory DLBCL, PMBCL, and FL3B

Feb 12, 2022 03:49 CST Updated 03:49
Bristol-Myers Squibb

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Committee for Medicinal Products for Human Use

Committee for Medicinal Products for Human Use (CHMP)The Committee for Medicinal Products for Human Use (CHMP) is the committee within the European Medicines Agency (EMA) responsible for human medicines. The CHMP replaced the former Committee for Proprietary Medicinal Products (CPMP) in May 2004.The CHMP plays a vital role in the authorization of medicines in the European Union (EU). In the centralized procedure, the CHMP is responsible for: 1) conducting initial assessments of marketing authorization applications across the EU; assessing modifications or extensions to existing marketing authorizations (“variations”); considering recommendations from the Agency’s Pharmacovigilance Risk Assessment Committee regarding the safety of medicines on the market, and, where necessary, advising the European Commission to amend the marketing authorization of a medicinal product, or to suspend or withdraw it from the market.The CHMP also evaluates medicines authorized at the national level that are referred to the EMA, with the aim of maintaining a harmonized position throughout the EU.Furthermore, the CHMP and its working groups promote the development of medicines and pharmaceutical regulation by: providing scientific advice to companies researching and developing new medicines; developing scientific and regulatory guidelines to assist pharmaceutical companies in preparing marketing authorization applications for human medicines; and collaborating with international partners to harmonize regulatory requirements.


News on February 11, 2022 /BioValleyBIOON/ -- Bristol-Myers Squibb (BMS) recently announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion, recommending the approval of the CD19 CAR-T cell therapy Breyanzi (lisocabtagene maraleucel, liso-cel):For the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma (PMBCL), and follicular lymphoma grade 3B (FL3B) who have received two or more prior lines of systemic therapy.Now, the CHMP opinion will be submitted to the European Commission (EC) for review, which typically makes a final decision within approximately 2 months (67 days).

Breyanzi is an autologous, CD19-directed, chimeric antigen receptor (CAR) T-cell therapy with a defined composition and 4-1BB co-stimulatory domain. Breyanzi consists of purified CD8+ and CD4+ T cells in a specific ratio (1:1), and the 4-1BB signaling enhances the expansion and persistence of Breyanzi.

In February 2020, Breyanzi was approved by the United States.FDAApproved for the treatment of adult patients with R/R LBCL who have received two or more prior lines of systemic therapy, including unspecified diffuse large B-cell lymphoma (DLBCL, including DLBCL arising from indolent lymphoma), high-grade B-cell lymphoma (HGBL), PMBCL, and FL3B. Breyanzi is not indicated for the treatment of patients with primary central nervous system (CNS) lymphoma. Additionally, Breyanzi has also been approved in Japan for the treatment of third-line or later R/R LBCL and FL.

The positive review opinion of the CHMP is based on the results of the TRANSCEND NHL 001 trial and additional data from the TRANSCEND WORLD study. Among these, the TRANSCEND NHL 001 is the largest pivotal trial conducted in R/R LBCL patients after second-line treatment. These studies evaluated patients with R/R DLBCL, PMBCL, and FL3B, including those with extensive histology and high-risk diseases, as well as patients receiving Breyanzi treatment both in inpatient and outpatient settings.

Anne Kerber, Senior Vice President of BMS Cell Therapy Development, stated: "This positive opinion from the CHMP is an important milestone, recognizing Breyanzi as a differentiated cell therapy with the potential to address unmet medical needs for patients with aggressive lymphoma in the EU who have limited treatment options. We look forward to the decision from the European Commission and will continue to accelerate research in cell therapies to develop new treatment options for patients with difficult-to-treat blood cancers." (Bioon.com)