FDA news: Breast cancer, melanoma agents win fast track, orphan drug status
Source: Healio, February 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 CFI-402257 (Treadwell Therapeutics), a threonine kinase inhibitor, for treatment of adults with ER-positive/HER2-negative advanced breast cancer after disease progression on prior CDK 4/6 inhibitors and endocrine therapy, both as a monotherapy and in combination with fulvestrant.
2. The FDA granted orphan drug designation to LNS8801 (Linnaeus Therapeutics), an orally bioavailable and highly specific G protein-coupled estrogen receptor agonist, for treatment of patients with metastatic cutaneous melanoma.