Overview
The US Food and Drug Administration (FDA) is recommending that sponsors include the collection of data on ovarian toxicity in the development of cancer drugs. The agency has warned that these drugs may be linked to infertility and other conditions, such as early menopause and early onset cardiovascular disease. In addition, it highlighted the scarcity of data that could clarify the long-term impacts on patients after treatment.
Introduction
In November, the FDA released a draft guidance for cancer drug sponsors, highlighting the importance of collecting data on clinical measures and biomarkers in premenopausal women who may face infertility and other morbidities due to treatment. The document emphasizes that ovarian toxicity should be considered a safety endpoint in clinical trials involving this audience and integrated into drug development strategies aimed at premenopausal patients.
Ovarian dysfunction can lead to infertility and long-term conditions associated with early menopause and estrogen deficiency, such as vasomotor symptoms, sexual dysfunction, osteoporosis and increased risk of early cardiovascular disease.
The FDA has highlighted the lack of data on ovarian toxicity in cancer drug trials. The agency pointed out that between 2008 and 2019, only 9% of phase 3 clinical trials for (neo)adjuvant breast cancer included ovarian function as a pre-specified endpoint. In addition, only 20% of these studies collected data on ovarian function before and after the intervention, and most were limited to recording information related to menstrual status.
The assessment of ovarian toxicity in cancer clinical trials is essential to ensure that patients and doctors have information about the possible long-term impacts of treatments on ovarian function, allowing informed decisions to be made about anticancer agents.
FDA Recommendations
The Guidance Suggests that Sponsors:
- Consult with reviewers at the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) in advance if they plan to include premenopausal adult women, especially those with a high probability of survival.
- Evaluate ovarian toxicity in clinical trials.
- Collect gynecological history data, including menstrual history, pregnancy information and number of live births.
- Collect biomarkers such as serum anti-müllerian hormone (AMH), serum follicle-stimulating hormone (FSH) and serum estradiol (E2), preferably between days 3 and 5 of the follicular phase of the menstrual cycle.
Conclusion
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References
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