FDA granted accelerated approval to Novartis AG’s HDAC inhibitor Farydak (panobinostat) for third-line treatment of multiple myeloma even though the drug’s Phase III confirmatory trial will not begin for approximately three years.
The agency’s approval letter includes two post-marketing trial requirements as a condition for accelerated approval: a Phase II multiple-dose study and a Phase III placebo-controlled trial.
Read the full article – start your free trial today!
Join thousands of industry professionals who rely on Pink Sheet for daily insights
- Start your 7-day free trial
- Explore trusted news, analysis, and insights
- Access comprehensive global coverage
- Enjoy instant access – no credit card required
Already a subscriber?