Seven more PDUFA dates in August
After starting the month with two approvals, FDA’s remaining decisions include Gilead’s seladelpar, Regeneron’s BCMAxCD3 bispecific
FDA hit the ground running in August, approving two therapeutics on day one, with one of those decisions coming ahead of schedule. The agency has at least seven more target action dates on its August roster.
Thursday’s accelerated approval of Tecelra afamitresgene autoleucel from Adaptimmune Therapeutics plc (NASDAQ:ADAP) came two days before the PDUFA date, and marked the first U.S. approval of an engineered cell therapy for a solid tumor. The MAGEA4-targeting T cell therapy is indicated for advanced MAGE-A4+synovial sarcoma in patients with certain HLA types who have received prior chemotherapy. In the Phase II SPEARHEAD-1 trial, Tecelra led to an objective response rate of 43% and a median duration of response of 6 months. ...
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