• Center on Health Equity & Access
  • Clinical
  • Health Care Cost
  • Health Care Delivery
  • Insurance
  • Policy
  • Technology
  • Value-Based Care

FDA Open to Surrogate Endpoints in Lung Cancer

Article

Pharmaceutical companies can expect accelerated drug development by using alternate endpoints instead of the gold standard of OS and PFS for oncology molecules.

Companies will be permitted to use several types of clinical trial endpoints to show the efficacy of drugs intended to treat non-small cell lung cancer (NSCLC), the FDA confirmed in a new guidance document released this week.

The final guidance document, Clinical Trial Endpoints for the Approval of Non-Small Cell Lung Cancer Drugs and Biologics, is intended to clarify the evidence FDA is willing to accept in the review of new NSCLC drugs.

Read the complete article at: http://bit.ly/1JghIHB

Source: Regulatory Guidance Professional Society

Related Videos
Nicoletta Colombo, MD, PhD
Dr Brian Mulherin
Dr Brian Koffman
Dr Brian Mulherin
Dr Vivek Subbiah
Dr Scott Soefje
Dr Scott Soefje
Dr Mark Fendrick
Dr Vishnukamal Golla
Related Content
© 2025 MJH Life Sciences
AJMC®
All rights reserved.