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DATA GRAPHICS | Data Byte

At least nine PDUFA dates on deck in March

Four submissions under FDA priority review

March 1, 2022 2:15 AM UTC

At least nine therapies have PDUFA dates in the month of March, four of which are under priority review.

FDA is slated to make its first decision of the month on March 19, on the priority review of a BLA for relatlimab from  Bristol Myers Squibb Co. (NYSE:BMY) to treat melanoma. Relatlimab, an anti-LAG3 mAb, is the first checkpoint inhibitor against a target other than CTLA-4 or PD-(L)1 to reach regulatory review. In the Phase II/III RELATIVITY-047 study, relatlimab plus Opdivo nivolumab led to 10.1 months of PFS vs. 4.6 months with the PD-1 inhibitor alone. ...

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