EMA OKs BMS/bluebird bio’s CAR-T Abecma For Multiple Myeloma

Other EU Recommendations Include Astellas’s Roxadustat & BioMarin’s Vosoritide

A gene therapy for multiple myeloma, a new drug for achondroplasia, and the first biosimilar version of Roche’s Lucentis are among eight products recommended for EU marketing authorization this week.

Gene editing genes therapy concept with nurse and DNA lab technician medical laboratory
A gene therapy for multiple myeloma could soon be approved in Europe • Source: Shutterstock

The European Medicine Agency’s human medicines committee, the CHMP, has delivered a positive opinion on Bristol Myers Squibb Company/bluebird bio’s CAR T-cell therapy, Abecma (idecabtagene vicleucel), the first cell-based gene therapy for patients with multiple myeloma.

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Approvals

EU Biosimilar Filings, Opinions And Approvals

 

A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.

New EU Approvals

 

The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include four new products, one of which is Tivdak, Pfizer/Genmab’s treatment for previously treated recurrent or metastatic cervical cancer.

Leqembi Launch Set For Germany & Austria After Winning EU Approval At Last

 

Eisai is working on securing reimbursement across the EU for Leqembi now that the Alzheimer’s disease treatment has secured marketing approval from the European Commission.

African Medicines Agency Set To Launch With New Leader In April

 

The African Medicines Agency is to appoint a director general and become operational at the end of this month.

More from Product Reviews

US FDA User Fee Collection Safe In Preliminary Trump 2026 Budget Plan

 
• By 

The preliminary White House 2026 budget plan cuts agency funding, but not so sharply that user fees are excluded from collection.

New EU Approvals

 

The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include four new products, one of which is Tivdak, Pfizer/Genmab’s treatment for previously treated recurrent or metastatic cervical cancer.

US CDC Panel Recommends Some 50-59 Year-Olds For RSV Vaccination

 

All RSV vaccines with US FDA approval for high-risk younger adult patients will be incorporated in US CDC’s Advisory Committee for Immunization Practices recommendations. Merck’s infant RSV antibody is on track for a June vote