The U.S. Food and Drug Administration (FDA) on Friday approved Bristol-Myers Squibb's cell-based gene therapy, Breyanzi, to treat adults with a type of cancer that starts in certain cells of the immune system.
The therapy was approved to treat patients with large B-cell lymphoma who have not responded to, or have relapsed after, at least two other types of systemic treatment.
The FDA approval was granted to Bristol-Myers Squibb's unit Juno Therapeutics Inc. Sales of the therapy are expected to top $100 mln in 2021, according to analysts' estimates.
The FDA said the treatment's label will carry a warning that it has the potential to cause severe side effects, including cytokine release syndrome.
The FDA also mandates that healthcare facilities that dispense Breyanzi be specially certified.
Breyanzi, previously known as liso-cel, was picked up by Bristol-Myers as one of the key pipeline assets in its more than $74 billion purchase of Celgene.
As part of that deal, Celgene shareholders would have received a $9 per share payment if three of Celgene’s top pipeline assets were approved by certain dates. They lost out on that payment because Breyanzi did not receive approval by the end of 2020.
Large B-cell lymphoma is the most common type of non-Hodgkin lymphoma in adults, representing about one in three newly diagnosed non-Hodgkin lymphoma cases each year.
(Reporting by Vishwadha Chander in Bengaluru; Editing by Aditya Soni)
