AstraZeneca Vice President, Head of Breast Cancer Franchise, Discusses Impact of Truqap Approval

Breakthrough Therapy designation for survodutide was based on preliminary clinical data showing potential improvement in patients with non-cirrhotic metabolic dysfunction-associated steatohepatitis over existing therapies.

Laura Johnson, senior director, sales, life sciences, Loftware, discusses scenarios where unclear labeling led to challenges for patient outcomes.

Approval was based on results from Phase I clinical safety studies, which demonstrated that using three tubes of Ameluz maintained similar safety and systemic exposure levels as one tube in treating actinic keratosis in patients undergoing photodynamic therapy.

Approval of Cologuard Plus follows results from the BLUE-C study, which demonstrated a 95% sensitivity for detecting colorectal cancer.

Approval for Opdivo was based on results from the CheckMate-77T trial, which demonstrated that the combination significantly improved event-free survival and pathologic complete response in adults with resectable non-small cell lung cancer without EGFR or ALK rearrangements.

Priority Review was based on data from the ECHO Phase III trial, which demonstrated that a combination of Calquence, bendamustine, and rituximab reduced the risk of disease progression or death by 27% in patients with previously untreated mantle cell lymphoma.