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Latest From AstraZeneca PLC
Secura’s Copiktra: Trial Design, Shifting Standard Of Care Could Spell The End For Third-Line CLL/SLL
In concluding benefits do not outweigh risks in the drug’s current indication, US FDA advisory committee members cite concerns about survival data from the Phase III DUO trial, as well as the drug’s toxicities, safety issues with the PI3K inhibitor class, and the changing treatment landscape for chronic lymphocytic leukemia and small lymphocytic lymphoma.
VC funding slowed recently, but public company financings kept up a brisk pace with follow-on public offerings for Allakos and Alpine, private placements for Ventyx and Syros, and Albireo’s royalty deal. In restructuring updates, Biogen raised $592m in a real estate deal and Acerus is assessing options.
While the Phase IIb SOLANO trial of ION449 met its primary endpoint, AstraZeneca had set a high bar of 70% LDL cholesterol reduction for competitiveness that the study did not hit.
Agency’s recent approval of Enhertu, which has better response rate, sways some panel members to vote against Spectrum’s NSCLC drug. FDA’s Pazdur compares poziotinib’s dosing uncertainty to ‘building a house on quicksand.’
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