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Biotech Stocks Facing FDA Decision In April 2023

Roche Holding
Roche Holding

Roche Holding AG (RHHBY.OB) has sought FDA approval to expand the use of Polivy in combination with Rituxan plus cyclophosphamide, doxorubicin and prednisone (R-CHP) for patients with previously untreated diffuse large B-cell lymphoma (DLBCL).

The U.S. regulatory agency’s decision on the proposed use is expected on April 2, 2023.

Polivy in combination with bendamustine plus Rituxan was granted accelerated approval by the FDA for the treatment of adults with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL), who have received at least two prior therapies in June 2019.

The drug generated annual sales of 437 million Swiss francs in 2022, which represents an 85% rise from the previous year.

RHHBY.OB closed Thursday’s trading at $35.80, up 0.99%.