Australian access to FDA-approved breakthrough therapy designation medicines: a 10-year review-Reference-Cited by-同舟云学术

Australian access to FDA-approved breakthrough therapy designation medicines: a 10-year review

Published:2024-08-21 Issue:1 Volume:17 Page:
ISSN:2052-3211
Container-title:Journal of Pharmaceutical Policy and Practice
language:en
Short-container-title:Journal of Pharmaceutical Policy and Practice

Author:

Lingaratnam Senthil¹²^ORCID,Hussainy Safeera Yasmeen¹²³,Murphy Alexandra⁴,Perrin Cale⁴,Samuvel Melbin⁴,Mehrvarz Elahe⁴,Lim Chiao Xin⁴,Zalcberg John³⁵⁶

Affiliation:

1. Pharmacy Department, Peter MacCallum Cancer Centre, Melbourne, Australia

2. Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, Australia

3. School of Public Health and Preventive Medicine, Monash University, Clayton, Australia

4. Pharmacy, School of Health and Biomedical Sciences, RMIT University, Bundoora, Australia

5. Department of Medicine, University of Melbourne, Melbourne, Australia

6. Department of Medical Oncology, Alfred Health, Melbourne, Australia

Publisher

Informa UK Limited

Link

https://www.tandfonline.com/doi/pdf/10.1080/20523211.2024.2389120

Reference16 articles.

1. Breakthrough Therapy Designation Criteria Identify Drugs that Improve Clinical Outcomes for Patients: A Case for More Streamlined Coverage of Promising Therapies

2. Breakthrough-Therapy Designation — An FDA Perspective

3. Efficacy, Safety, and Regulatory Approval of Food and Drug Administration–Designated Breakthrough and Nonbreakthrough Cancer Medicines

4. Clinical benefit and cost of breakthrough cancer drugs approved by the US Food and Drug Administration

5. Breakthrough therapy-designated oncology drugs: are they rightfully criticized?