FDA News

FDA grants CAR T-cell therapy bb2121 breakthrough therapy designation for multiple myeloma

The FDA granted bb2121 — a chimeric antigen receptor T-cell therapy targeting B-cell maturation antigen — breakthrough therapy designation for the treatment of patients with relapsed or refractory multiple myeloma.

The agency based their decision on preliminary data from the ongoing phase 1 CRB-401 study, updated data from which are scheduled for presentation at the ASH Annual Meeting and Exposition in December. That study evaluated bb2121 (bluebird bio, Celgene) in heavily pretreated patients with multiple myeloma.

The chimeric antigen receptor (CAR) T-cell therapy also received PRIority MEdicines (PRIME) eligibility from the European Medicines Agency (EMA).

“Receiving breakthrough therapy designation and PRIME eligibility for bb2121 further underscores the potential of this novel cellular immunotherapy approach to multiple myeloma treatment,” Jay Backstrom, MD, chief medical officer and head of Global Regulatory Affairs for Celgene, said in a company-issued press release. “We will work closely with these agencies as we accelerate development of bb2121, a novel technology and therapy for patients with multiple myeloma.”

This therapy shows promise for heavily pretreated patients, who have limited options for treatment.

“Early data suggest that treatment with bb2121 has the potential to induce durable responses in this patient population,” David Davidson, MD, chief medical officer for bluebird bio, said in the release. “It is encouraging for both the FDA and EMA to identify bb2121 as a candidate for accelerated development as we continue our work with Celgene to bring this therapy to patients in need of new options.”

The FDA granted bb2121 — a chimeric antigen receptor T-cell therapy targeting B-cell maturation antigen — breakthrough therapy designation for the treatment of patients with relapsed or refractory multiple myeloma.

The agency based their decision on preliminary data from the ongoing phase 1 CRB-401 study, updated data from which are scheduled for presentation at the ASH Annual Meeting and Exposition in December. That study evaluated bb2121 (bluebird bio, Celgene) in heavily pretreated patients with multiple myeloma.

The chimeric antigen receptor (CAR) T-cell therapy also received PRIority MEdicines (PRIME) eligibility from the European Medicines Agency (EMA).

“Receiving breakthrough therapy designation and PRIME eligibility for bb2121 further underscores the potential of this novel cellular immunotherapy approach to multiple myeloma treatment,” Jay Backstrom, MD, chief medical officer and head of Global Regulatory Affairs for Celgene, said in a company-issued press release. “We will work closely with these agencies as we accelerate development of bb2121, a novel technology and therapy for patients with multiple myeloma.”

This therapy shows promise for heavily pretreated patients, who have limited options for treatment.

“Early data suggest that treatment with bb2121 has the potential to induce durable responses in this patient population,” David Davidson, MD, chief medical officer for bluebird bio, said in the release. “It is encouraging for both the FDA and EMA to identify bb2121 as a candidate for accelerated development as we continue our work with Celgene to bring this therapy to patients in need of new options.”