USFDA Guidance: Selective Approach to Safety Data Collection & Dosing Regimens of PD1 & PD-L1

Earlier today USFDA's Center for Drug Evaluation and Research (CDER) & Oncology Center of Excellence released the updated final guidance on "Pharmacokinetic-Based Criteria for Supporting Alternative Dosing Regimens of Programmed Cell Death Receptor-1 (PD-1) or Programmed Cell Death-Ligand 1 (PD-L1) Blocking Antibodies for Treatment of Patients with Cancer".

Also yesterday USFDA's CDER released final guidance on "E19 A Selective Approach to Safety Data Collection in Specific Late-Stage Pre-Approval or Post-Approval Clinical Trials".

Guidance: Pharmacokinetic-Based Criteria for Supporting Alternative Dosing Regimens of Programmed Cell Death Receptor-1 (PD-1) or Programmed Cell Death-Ligand 1 (PD-L1) Blocking Antibodies

PD-1 and PD-L1 blocking antibody products have been developed for various cancer indications. These antibodies are usually administered intravenously.

The purpose of this guidance is to provide recommendations to sponsors of investigational new drug applications (INDs) and biologic license applications (BLAs) regarding the use of pharmacokinetic (PK) criteria to support the approval of alternative dosing regimens for antibodies that block programmed cell death receptor-1 or programmed cell death-ligand 1.

Guidance: E19 A Selective Approach to Safety Data Collection in Specific Late-Stage Pre-Approval or Post-Approval Clinical Trials

Selective safety data collection refers to the reduced collection of certain types of data in a clinical trial after thorough consideration of factors that would justify such an approach. By tailoring the method and streamlining the approach to safety data collection, it may be possible to carry out clinical trials with greater efficiency.

The purpose of this guidance is to provide international harmonized guidance on the collection of selective safety data in pre-approval or post-approval late-stage clinical trials.