MM-151

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.

Affimed Announces FDA Clearance of IND to Commence First-in-Human Phase 1/2a Study of AFM24 for the Treatment of EGFR-Expressing Cancers

Retrieved on: 
Thursday, November 7, 2019

The IND clearance of AFM24 enables us to proceed with our planned Phase 1/2a study aimed at establishing safety and identifying initial signals of efficacy in patients with EGFR-expressing solid tumors, said Dr. Adi Hoess, Chief Executive Officer of Affimed.

Key Points: 
  • The IND clearance of AFM24 enables us to proceed with our planned Phase 1/2a study aimed at establishing safety and identifying initial signals of efficacy in patients with EGFR-expressing solid tumors, said Dr. Adi Hoess, Chief Executive Officer of Affimed.
  • The initial goal of the planned Phase 1/2a study is to determine the maximum tolerated dose and recommended Phase 2 dose of AFM24, as well as to evaluate the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy.
  • The second part of the study is designed to evaluate the preliminary efficacy of AFM24 in patients with select solid tumor subtypes.
  • Affimed (Nasdaq: AFMD) is a clinical stage biopharmaceutical company committed to giving patients back their innate ability to fight cancer.