Products

Date: 2017-11-16

Type of information: Granting of the Breakthrough Therapy status

Product name: bb2121 anti-BCMA CAR T cells - autologous T-lymphocytes transduced with anti-BCMA02 CAR lentiviral vector encoding a chimeric antigen receptor (CAR) specific for the human B cell maturation antigen

Compound: autologous T-lymphocytes transduced with anti-BCMA02 CAR lentiviral vector encoding a chimeric antigen receptor (CAR) specific for the human B cell maturation antigen

Therapeutic area: Cancer - Oncology - Rare diseases

Action mechanism: cell therapy/immunotherapy product/gene therapy/CAR-T cell therapy  

Company: Celgene (USA - NJ) Bluebird bio (USA - MA)

Disease: multiple myeloma

Latest news:

• • On November 16, 2017, Celgene and bluebird bio announced that bb2121, a chimeric antigen receptor T-cell (CAR-T) therapy targeting b-cell maturation antigen (BCMA) in previously treated patients with multiple myeloma, has been granted Breakthrough Therapy Designation by the FDA and PRIority MEdicines (PRIME) eligibility by the European Medicines Agency (EMA).
• BTD designation and PRIME eligibility for bb2121 were based on preliminary clinical data from the ongoing phase 1 study CRB-401. Updated data from CRB-401 is scheduled to be presented at the 59th annual meeting of the American Society of Hematology in Atlanta during an oral presentation on Dec. 11.
•   • On May 11, 2016, the FDA has granted orphan drug designation for autologous T-lymphocytes transduced with anti-BCMA02 CAR lentiviral vector encoding a chimeric antigen receptor (CAR) specific for the human B cell maturation antigen for the treatment of multiple myeloma.

 

Patents:

Submission of marketing authorization application USA :

Submission of marketing authorization application UE:

Withdrawal of marketing authorization application USA:

Withdrawal of marketing authorization application UE:

US authorization:

UE authorization:

Favourable opinion UE:

Favourable opinion USA:

Orphan status USA: 2016-05-11

Orphan status UE: 2017-04-20

Pediatric exclusivit _USA:

Pediatric exclusivity UE:

OTC status:

Other news:

Is general: Yes