Scientific Paper Revew-U.S. FDA Botanical Cancer Drug Current INDs

SILVER SPRING, MD - A recent analysis, published in Therapeutic Innovation & Regulatory Science, by researchers including Jin-Young K. Park, Daniel Lee, Lixin Rui, Xiaoyue Gao, M. Scott Furness, and Charles Wu, examines botanical investigational new drug applications (INDs) submitted to the U.S. Food and Drug Administration (FDA) for cancer management. The study provides a comprehensive overview of regulatory submission profiles and review experiences for oncologic botanical drug research and development

The FDA has received over 700 botanical INDs across various therapeutic areas since 1984, with the largest number pertaining to cancer management. This study specifically analyzed 254 botanical INDs with oncologic indications and 485 non-oncologic botanical INDs received by the FDA between March 1984 and December 2020.

Key findings from the analysis include:

• Initial 30-Day Actions: A higher percentage of oncologic botanical INDs (69%) received an initial 30-day "safe-to-proceed" designation compared to non-oncologic botanical INDs (58%). This action permits the initiation of clinical investigations.

• Current Regulatory Status: As of December 2020, 82 (32%) of the oncologic botanical INDs and 171 (35%) of the non-oncologic botanical INDs were active, indicating ongoing clinical investigations.

• Clinical Trial Phases: Of the oncologic botanical INDs, 137 were submitted for Phase 1 trials (46 active), 111 for Phase 2 trials (33 active), and 6 for Phase 3 trials (3 active).

• Primary Purpose of Trials: The primary purposes for oncologic botanical INDs were basic research (38%), treatment (26%), supportive care (20%), and prevention (14%).

• Specific Tumor Types Investigated: The majority of oncologic botanical INDs (71%) focused on specific solid tumors, with prostate and breast tumors representing more than one-third of these cases. Hematologic malignancies accounted for 9% of the submissions.

The authors note that the FDA's regulatory approach for botanical drugs considers their inherent complexity, including challenges in identifying active components and ensuring quality consistency. The agency's 2016 Guidance for Industry for the Development of Botanical Drugs provides recommendations for facilitating drug development and ensuring batch-to-batch consistency.

The study concludes that over 80 active botanical oncologic INDs were identified, with several in the late phases of drug development. This indicates a pipeline of botanical drug products under investigation for cancer management, encompassing basic scientific research, various cancer treatments, supportive care, and cancer prevention.