Page 19 - Priority Review News Today

A tumor-agnostic approval would be a significant development in the advance of antibody-drug conjugates (ADCs), which are designed to deliver a potent, cancer-fighting payload into a tumor while sparing nearby tissues.

The FDA granted priority review to a sBLA seeking the approval of alectinib as adjuvant treatment after surgery for early-stage ALK-positive NSCLC.

2023 Sets Stage for Future Growth Potential: Completed Seagen Acquisition, Creating World-Class Oncology Organization; Launched Significant Number of New Products and Indications; and Realigned...

PRINCETON, N.J.--(BUSINESS WIRE)--Jan 30, 2024--

U.S. FDA grants both FL and MCL applications Priority Review Applications based on results from TRANSCEND FL and TRANSCEND NHL 001, in which Breyanzi demonstrated clinically meaningful benefit with...

Liso-cel is a CD19-directed genetically modified autologous T cell immunotherapy.

Application based on results from DESTINY-PanTumor02 trial and supported by additional ENHERTU data Submission to be reviewed under FDA Real Time Oncology Review and Project Orbis If approved,...

AstraZeneca (AZN.L, AZN) and Daiichi Sankyo (DSKYF.PK) announced Monday that the Food and Drug Administration has accepted and granted Priority Review to the supplemental Biologics License Application or sBLA for ENHERTU (fam-trastuzumab deruxtecan-nxki) in the US for patients with metastatic HER2-positive solid tumors.

Enhertu is under Priority Review for the treatment of previously treated adults with unresectable or metastatic HER2+ IHC 3+ solid tumors.

AstraZeneca and Daiichi Sankyo's supplemental Biologics License Application (sBLA) for Enhertu (trastuzumab deruxtecan) has been accepted and granted Priority Review in the US for the treatment of adult patients with unresectable or metastatic HER2-positive (immunohistochemistry [IHC] 3+) solid tumours who have ...