Enhertu has now been granted five Breakthrough Therapy Designations, including three in breast cancer and one in both lung and gastric cancers
Enhertu is a HER2-directed antibody drug conjugate (ADC) being jointly developed by AstraZeneca and Daiichi Sankyo.
Eribulin Mesylate Injection, 1 mg/2 mL (0.5 mg/mL) single-dose vials is the bioequivalent to the reference listed drug (RLD) Halaven injection of Eisai, Inc.
The recommendation is powered by blockbuster results from the pivotal Phase III SERENA-6 trial
The drug also showed a manageable safety profile, with just 6.4% of patients stopping treatment due to side effects. No new safety concerns emerged
Giredestrant shows promise despite missing primary goal
The NDA filing is supported by results from the phase III evERA Breast Cancer study
The findings, based on an exploratory analysis, indicate that CD47 expression may predict which patients benefit most from the therapy
CX-5461 is “the world's first and most advanced G-quadruplex (G4) stabilizer in development
The move strengthens GBL’s clinical-stage presence in the United States
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