– draft guidance comment period ends 15DEC2018
Interested parties have about a month to comment on the draft guidance for those planning to use minimal residual disease (MRD) as a biomarker in oncology clinical trials for treatment of blood diseases. Released in October, the guidance discusses how MRD was developed and validated, the challenges presented by using it as measure of disease burden in leukemia and other hematologic cancers, and considerations for the choice of test method and sample collection. The guidance also discusses specific considerations for use of the test in trials for 6 forms of leukemia:
- Acute Lymphoblastic Leukemia
- Acute Myeloid Leukemia
- Acute Promyelocytic Leukemia
- Chronic Lymphocytic Leukemia
- Chronic Myeloid Leukemia
- Multiple Myeloma
I discussed the draft with a colleague who is an expert in oncology clinical trials. He noted most trials are already monitoring for MRD, but the measure comprises only 1-2% of the data from a trial, as the primary endpoints continue to be complete response or progression free survival. MRD can be useful as supplemental data that could lead to faster approval. Testing for years has been by flow cytometry supplemented with PCR, but most pathologists now feel next generation sequencing will be necessary to advance MRD as a significant endpoint. I’m not so sure next generation sequencing as it currently exists will produce the desired results – readers should expect a future post on this topic.
Submit your comments on the draft at Docket FDA-2018-D-3090-0001.
Text Copyright © 2018 Katrina Rogers