Bristol Myers Squibb Receives Positive CHMP Opinion for Abecma (idecabtagene vicleucel), the First Anti-BCMA CAR T Cell Therapy for Relapsed and Refractory Multiple Myeloma in the EU
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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.
European Union
The European Union (German: Europäische Union; French: Union européenne), abbreviated as the EU, is headquartered in Brussels, the capital of Belgium. It evolved from the European Communities and originally had six founding member states: Germany, France, Italy, the Netherlands, Belgium, and Luxembourg. The Union currently has 28 member states and 24 official languages.In December 1991, the European Council meeting in Maastricht adopted the Treaty on European Union, commonly known as the Maastricht Treaty. On November 1, 1993, the Maastricht Treaty officially entered into force, marking the formal establishment of the European Union. In 2012, the EU was awarded the Nobel Peace Prize.Donald Tusk serves as President of the European Council, and Antonio Tajani is President of the European Parliament. Jean-Claude Juncker, former Prime Minister of Luxembourg, is President of the European Commission.The EU’s treaties have been amended multiple times, and its operations are governed by the Treaty of Lisbon. Politically, all member states are democracies (according to The Economist’s 2008 Democracy Index). Economically, it constitutes the world’s second-largest economic entity (with Germany, France, and Italy being members of the G8). Militarily, the vast majority of EU member states are also members of the North Atlantic Treaty Organization (NATO).
European Commission
The European Commission, abbreviated as the EU Commission, is a supranational body under the European Union. Within the EU political system, the European Commission primarily undertakes executive tasks, thus being roughly equivalent to the government in a national system. However, the European Commission has other functions as well. In particular, except for the few circumstances specified in the treaties, the European Commission is the only institution with legislative power in the EU legislative process.
Compiled & Translated by | River
Recently, according to foreign media reports, Bristol-Myers Squibb (BMS) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended granting conditional marketing authorization for Abecma (idecabtagene vicleucel, ide-cel). The drug is a B-cell maturation antigen (anti-BCMA)-directed chimeric antigen receptor (CAR) T-cell therapy indicated for the treatment of adult patients with relapsed/refractory multiple myeloma (R/R MM) who have previously received at least three prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody. The CHMP's recommendation will now be reviewed by the European Commission (EC), which holds the authority to approve medicines for the European Union (EU).
The CHMP adopted a positive opinion based on the results of the pivotal Phase II KarMMa study, which evaluated the efficacy and safety of Abecma in 128 patients with heavily pretreated and highly refractory multiple myeloma. These patients had received at least three prior classes of therapy (including an immunomodulatory drug, a proteasome inhibitor, and an anti-CD38 antibody) and were refractory to their last line of treatment. The efficacy analysis population comprised 100 patients who received Abecma at a dose of 300 to 460 × 10⁶ CAR-positive T cells. Among these patients, 88% had received four or more prior lines of therapy, and 85% were triple-class refractory.
The results showed that in the efficacy-evaluable population (n=100), the overall response rate (ORR) following a single infusion of Abecma was 72% (95% CI: 62–81), with 28% of patients achieving a stringent complete response (sCR; 95% CI: 19–38). Responses were rapid and durable, with a median time to response of 30 days (range: 15–88 days) from infusion. The median duration of response was 11 months (95% CI: 10.3–11.4) among all responders, and 19 months (95% CI: 11.4–NE) among patients who achieved sCR. Among the 28 patients who achieved sCR, an estimated 65% (95% CI: 42%–81%) maintained a response for at least 12 months.
In this study, the safety of Abecma in treated patients has been well established. Cytokine release syndrome (CRS) and neurotoxicity (NT) were predominantly low-grade, with a predictable early onset and rapid resolution.
Notably, Abecma is the world’s first BCMA-directed CAR-T cell therapy to receive regulatory approval, having been granted U.S. FDA approval in March of this year for the treatment of multiple myeloma. It is also the first CAR-T cell therapy to receive a positive opinion from the CHMP for relapsed and refractory multiple myeloma.
The EC is expected to issue a final decision within 67 days of receiving the CHMP opinion. This decision will apply to all EU Member States, as well as Iceland, Norway, and Liechtenstein. The EMA previously granted Abecma eligibility for the PRIority MEdicines (PRIME) scheme for the treatment of relapsed and refractory multiple myeloma.
References:
1.Bristol Myers Squibb Receives Positive CHMP Opinion for Anti-BCMA CAR T Cell Therapy Abecma (idecabtagene vicleucel) for Relapsed and Refractory Multiple Myeloma
2.U.S. Food and Drug Administration approves Bristol Myers Squibb’s and bluebird bio’s Abecma (idecabtagene vicleucel), the First Anti-BCMA CAR T Cell Therapy for Relapsed or Refractory Multiple Myeloma
*Disclaimer: This article is written by a contributing author to Sina Medical News. The views expressed are solely those of the author and do not represent the position of Sina Medical News.