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Biotech Stocks Facing FDA Decision In March 2023

Roche Holding
Roche Holding

An advisory panel of outside experts is slated to review Roche Holding AG’s (RHHBY) lymphoma drug Polivy for expanded use in combination with Rituxan plus cyclophosphamide, doxorubicin and prednisone for treating adult patients with previously untreated diffuse large B-cell lymphoma on March 9, 2023.

The final decision of the FDA on the expanded use of Polivy is due on Apr 2, 2023.

The regulatory agency usually follows the recommendations of its panels although it is not required to do so.

Polivy received FDA approval in June 2019 for use in combination with bendamustine plus Rituxan for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma, who have received at least two prior therapies.

The drug recorded annual sales of CHF 437 million in 2022, up 85% over 2021.

RHHBY.OB closed Monday’s (Feb 27, 2023) trading at $36.74, down 0.19%.