The U.S. Food and Drug Administration (FDA) granted priority review for expanded use of Bristol Myers Squibb's Breyanzi as a second line treatment of adults with relapsed or refractory large B-cell lymphoma (LBCL) after failure of first-line therapy.
The FDA is expected to make a decision by June 24.
The company's supplemental biologics license application was backed by data from a phase 3 trial, dubbed TRANSFORM.
The company said that in the trial Breyanzi showed significant and clinically meaningful improvements over salvage chemotherapy followed by high-dose chemotherapy plus autologous stem cell transplant, which has been the standard of care for more than 20 years.
Breyanzi is approved in the U.S. to treat adult patients with relapsed or refractory LBCL after two or more lines of systemic therapy.
The drug also carries a Boxed Warning for the risks of cytokine release syndrome and neurologic toxicities and is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the BREYANZI REMS.