Bristol Myers' (BMY) sBLAs for Breyanzi Get FDA Priority Tag
Bristol Myers Squibb Company (BMY) announced that the FDA has accepted its two supplemental biologics license applications (sBLA) seeking label expansion for Breyanzi in two new indications. The sBLAs are seeking approval for Breyanzi for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) and relapsed or refractory mantle cell lymphoma (MCL) after a Bruton tyrosine kinase inhibitor (BTKi).Breyanzi is a CD19-directed CAR T cell therapy with a 4-1BB costimulatory domain, whic ...