The US FDA has issued the policy and procedures on Good Review Practice: Clinical and Consultative Review of Drugs to Reduce the Risk of Cancer.
The regulatory authority’s Manual of Policies And Procedures (MAPP) provides an overview of the clinical consultative review process in the Office of New Drugs (OND) within the Centre for Drug Evaluation and Research (CDER) for investigational new drug applications (INDs), new drug applications (NDAs), biologics licence applications (BLAs), and supplemental NDA and BLA applications for drugs to reduce the risk of cancer.
The MAPP procedures are intended to ensure quality and consistency in clinical consultative reviews. It also describes the sign-off policies and procedures for INDs, NDAs, BLAs, and supplements for drugs to reduce the risk of cancer. It applies to interactions between the Office of Haematology and Oncology Products (OHOP) and consultants residing in other CDER divisions and other offices or centres.
Drugs to reduce the risk of cancer are an important focus of drug development. Expertise in cancer epidemiology and pathophysiology, in the design and analysis of chemoprevention trials, and in assessment of adverse events and toxicity in a healthy but at-risk population is important for the evaluation of the safety and efficacy of these drugs in CDER.
In addition, collaboration with sponsors, oncology professional societies, clinical trial participants and advocates, the National Cancer Institute (NCI), and other important stakeholders, is critical in facilitating the development and review of these drugs. For these reasons, all drugs to reduce the risk of cancer, except those intended to reduce non-melanoma skin cancer, are reviewed within OHOP, said the regulatory authority.
OND’s consult request process is well-established. MAPP 6025.3 Clinical Consultative Review of Drugs Regulated Within OND describes consultative interactions between specific subject matter review divisions (SSMRDs) in OND.
Regulatory project managers' (RPMs) should instruct sponsors who intend to develop a new molecular entity for cancer risk reduction to submit the protocol and required non-clinical information as a new IND to OHOP.
All cancer prevention INDs, except for non-melanoma skin cancer risk reduction will be assigned to OHOP, using the standard document receipt and processing procedures.
Applications for prevention indications will be tracked in the appropriate databases using the specific therapeutic classification code for cancer prevention.
New cancer prevention submissions for drugs with previously established applications for a different indication require a new IND. The RPM and medical team leader are responsible for identifying prevention protocols incorrectly submitted to an existing IND. Further, the RPM will inform the sponsor on the need to resubmit the protocol as a new IND to the appropriate division within OHOP.
It is the OHOP signatory authority which could accept or reject consultative advice. MAPP requires OHOP to discuss rejection of major recommendations with the SSMRD. If the latter feels strongly that rejection of a major recommendation will affect the assessment of safety or efficacy of the drug under review, it is encouraged to try to resolve these disagreements with clear communication with OHOP, said the regulatory authority.