Regulatory Strategies for the Development of Adjunctive Cancer Chemotherapies

A key to obtaining timely approval of a new drug application for an adjunctive chemotherapy for cancer is the early development of a well-researched overall regulatory strategy. That strategy should contain an effective and detailed development plan, from preclinical assessments to the pivotal clinical trials design, always with the final desired labeling as the goal. This plan should include a carefully chosen and well-defined indication; established endpoints with scientific validity and clinical meaning that can pass regulatory scrutiny; adequate characterization of the patient population for the clinical trials; coordination of comparison studies with a currently marketed product approved for the same indication; plans for preclinical and clinical studies to sufficiently characterize toxicity; and upfront design of the data analyses such that subpopulations of patients may be evaluated on predefined safety and efficacy variables. The use of established scientific methodology in the construction of an overall development plan early in the evolution of a drug product can lead to a cost- and time-effective drug development program and a successful review process.