Today, the FDA published a draft guidance titled “Oncology Pharmaceuticals: Streamlined Nonclinical Safety Studies for Biologics and Conjugated Products: Guidance for Industry,” aimed at implementing streamlined approaches for nonclinical safety assessments of certain oncology pharmaceuticals. The draft guidance can be found here.
The document provides some interesting background on the evolution of the Agency’s thinking regarding non-clinical studies for oncology products over the years. It provides recommendations for the following oncology and conjugated products:
- Biologics
- PD-(L)1 blocking monospecific antibodies
- CD3 bispecific T-cell engagers
- Antibody-Drug Conjugates (ADCs) with cytotoxic payloads
The draft guidance also discusses what may be included to support a weight of evidence (WoE) evaluation.
The document notes that the “CDER oncology review divisions will determine whether the information included in the WoE risk assessment is sufficient to address the safety risks based on the totality of evidence.”
This draft guidance provides a framework for reaching both overall goals of streamlining the non-clinical toxicological evaluation and reducing required animal testing.
