Ipsen Receives FDA Fast Track Designation for Investigational Irinotecan Liposome Injection (ONIVYDE®) as a Second-Line Monotherapy Treatment for Small Cell Lung Cancer (SCLC)
Retrieved on:
Monday, November 30, 2020
ONIVYDE is not indicated as a single agent for the treatment of patients with metastatic adenocarcinoma of the pancreas.
Key Points:
- ONIVYDE is not indicated as a single agent for the treatment of patients with metastatic adenocarcinoma of the pancreas.
- Programs with Fast Track designation may benefit from early and frequent interactions with the FDA over the course of drug development.
- PharmaEngine is a commercial stage oncology company headquartered in Taipei and is responsible for the commercialization of ONIVYDE in Taiwan.
- Limitation of Use: ONIVYDE is not indicated as a single agent for the treatment of patients with metastatic adenocarcinoma of the pancreas.