FDA news: License applications accepted for melanoma, endometrial cancer therapies
Source: Healio, June 2023
The FDA announced several regulatory actions the past few weeks.
Here is an overview of decisions that may be relevant to your practice.
1. The agency granted fast track designation to IMPT-314 (ImmPACT Bio) — a CD19/CD20 chimeric antigen receptor T-cell therapy — for the treatment of patients with B-cell mediated malignancies.
2. The FDA granted orphan drug designation to ATG-022 (Antengene) — a claudin 18.2-targeting antibody-drug conjugate — for the treatment of gastric cancer and pancreatic cancer.