Newly approved gynecologic cancer treatment; Zejula use restricted; intrauterine system use extended; a second insulin product is approved as a biosimilar to Lantus; and an FDA Advisory Committee take a vote on tenapanor.
The approval was based on data from the SORAYA trial.
The decision to restrict the indication follows an FDA review of the double-blind, placebo-controlled phase 3 ENGOT-OV16/NOVA trial.
This month’s case involves an FDA Safety Communication regarding a device which later caused injury that led to the death of a patient.
Alymsys is a vascular endothelial growth factor inhibitor.
Association remains regardless of the presence of most other risk factors for ovarian cancer
Effect estimate stronger for CIN2+ for disease related to HPV subtypes HPV 16 or HPV 18
The accelerated approval was based on data from two phase 2 trials: the ROAR basket study and the NCI-MATCH Subprotocol H study.
Mirvetuximab soravtansine is an antibody-drug conjugate comprised of a FRα-binding antibody, a cleavable linker, and a potent tubulin-targeting agent.
The approval was based on data demonstrating that the biosimilar product and the reference product were highly similar, and that there were no clinically meaningful differences between the agents.
