Excitement over emerging chimeric antigen receptor T-cell (CAR-T) therapies has put hematologic oncology in the headlines, but FDA's blood cancer reviewers are also busy with a full pipeline of new agents – including at least six new molecular entities and novel biologics with user fee in goals in 2017 – as well as the line extensions and expanded indications collecting around the agents that were novel in the recent past.
New hematologic cancer agents under review represent a high level of both novelty and medical advances. The individualized CAR-T candidates from Novartis AG and Kite Pharma Inc. both carry breakthrough therapy designations (BTDs), as do Pfizer Inc
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?