Good News For Immunomedics' Triple Negative Breast Cancer Trial
A Phase III trial testing the antibody-drug conjugate sacituzumab govitecan was stopped early for efficacy, boding well for the BLA pending at the US FDA.
You may also be interested in...
After accelerated approval in the US in April based on Phase II response rates, the company will seek full approval later this year based on a tripling of progression-free survival in a Phase III trial.
Keeping Track Of Approvals: US FDA Keeps Up Fast Pace In Oncology With Early Nods For Trodelvy, Pemazyre
The latest US FDA product approval news from the Pink Sheet FDA Performance Tracker.
Biotech firm chooses words carefully to wind its way through site inspection findings and CMC review concerns in hopes of winning its first FDA approval for a breakthrough breast cancer treatment.