Advancing Drug Development in Gynecologic Malignancies
| Autor: | Rebecca C. Arend, Robert L. Coleman, Anil K. Sood, Deborah K. Armstrong, Thomas J. Herzog, Gordon B. Mills, Sanjeeve Bala, Julia A. Beaver |
|---|---|
| Rok vydání: | 2019 |
| Předmět: |
Cancer Research
medicine.medical_specialty Genital Neoplasms Female medicine.medical_treatment Treatment outcome MEDLINE Antineoplastic Agents Article 03 medical and health sciences Antineoplastic Agents Immunological 0302 clinical medicine Drug Development Biomarkers Tumor Humans Medicine Regulatory science Molecular Targeted Therapy 030212 general & internal medicine State of the science Intensive care medicine Clinical Trials as Topic business.industry Extramural Immunotherapy Combined Modality Therapy Clinical trial Treatment Outcome Oncology Drug development Research Design 030220 oncology & carcinogenesis Female business |
| Zdroj: | Clin Cancer Res |
| ISSN: | 1557-3265 1078-0432 |
| Popis: | Gynecologic malignancies continue to be a major cause of morbidity and mortality in the United States despite recent advances in oncologic therapies. To realize the promise of immunotherapy and biomarker-driven approaches to improve clinical outcomes for patients, better communication among stakeholders in the drug development and approval pathways is needed. To this end, the FDA-AACR-SGO Drug Development in Gynecologic Malignancies Workshop brought together clinicians, patient advocates, researchers, industry representatives, and regulators in June 2018, to review the state of the science in gynecologic cancers and explore how scientific advances impact approval processes. Topics of discussion and key takeaways are summarized in this Perspectives in Regulatory Science and Policy article. Single-agent immunotherapies have demonstrated variable and often modest response rates among gynecologic cancers. Combination therapies and other novel approaches, such as cell-based therapies, may show improved efficacy compared with single-agent immunotherapies; however, utilizing innovative clinical trial designs will be necessary to progress further. Companion and complementary diagnostics inform physicians of potential benefits of specific therapeutics for patients; however, they serve different functions that have important regulatory implications, thus trialists should understand the distinctions between diagnostic types. PARP inhibitors hold great promise for treating ovarian cancers, both as monotherapies and in combination with chemotherapeutics, other targeted agents, and immunotherapies. Rare gynecologic cancers often exhibit unique molecular characteristics that can serve as effective targets to which novel therapeutics can be developed. This workshop highlighted the importance of future open discussions on scientific and regulatory challenges in drug development for gynecologic malignancies. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|