In the years since gaining an initial FDA approval for Breyanzi, Bristol Myers Squibb has worked hard to expand the reach of its cell therapy. For the third time in as many months, those efforts have yielded a label expansion at the FDA.
Bristol Myers Squibb’s Breyanzi secured FDA approval to treat certain patients with mantle cell lymphoma (MCL). The agency specifically endorsed the CAR-T therapy to treat adult patients with relapsed or refractory MCL who’ve received at least two other therapies, including one BTK inhibitor.
With the nod, Breyanzi becomes the first CAR-T cell therapy to gain FDA approval in four subtypes of non-Hodgkin lymphoma