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UPDATE 1-FDA approves Bristol-Myers' gene therapy for white blood cell cancer

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(Adds details of therapy, background)

Feb 5 (Reuters) - The U.S. Food and Drug Administration(FDA) on Friday approved Bristol-Myers Squibb'scell-based gene therapy, Breyanzi, to treat adults with a typeof cancer that starts in certain cells of the immune system.

The therapy was approved to treat patients with large B-celllymphoma who have not responded to, or have relapsed after, atleast two other types of systemic treatment.

The FDA approval was granted to Bristol-Myers Squibb's unitJuno 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 thatit has the potential to cause severe side effects, includingcytokine release syndrome.

The FDA also mandates that healthcare facilities thatdispense Breyanzi be specially certified.

Breyanzi, previously known as liso-cel, was picked up byBristol-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 havereceived a $9 per share payment if three of Celgene’s toppipeline assets were approved by certain dates. They lost out onthat payment because Breyanzi did not receive approval by theend of 2020.

Large B-cell lymphoma is the most common type of non-Hodgkinlymphoma in adults, representing about one in three newlydiagnosed non-Hodgkin lymphoma cases each year.(Reporting by Vishwadha Chander in Bengaluru; Editing by AdityaSoni)