Kandemir Esin Aysel
Turkish Medicines and Medical Devices Agency, Ankara, Turkey.
J Oncol Pharm Pract. 2023 Jan;29(1):191-207. doi: 10.1177/10781552221112015. Epub 2022 Jul 6.
This review aims to present the most recent results from clinical trials of targeted cancer drugs that led to the Food and Drug Administration approval in 2021 and reflect the changing treatment landscape of solid malignancies.
Novel approvals and supplemental approvals in 2021 were retrieved from the official web page of the Food and Drug Administration (Drugs@FDA). This review did not include approvals for generics, biosimilars, imaging, and diagnostics agents.
This review included 10 novel drugs approved for 11 indications and 10 already-approved drugs approved for 21 indications by the Food and Drug Administration in 2021. Novel approvals mainly were related to treating an orphan disease. In addition, one-third of the supplemental approvals were given for neoadjuvant or adjuvant treatment, while the number of indications for each tumor site was as follows: gastrointestinal (7), genitourinary (5), skin (3), lung (2), breast (2), thyroid (1), and cervix (1).
Targeted cancer treatments are gaining more importance than ever in treating malignant diseases. As the approval of targeted cancer drugs provides a possibility for patients and this trend is expected to continue in the future, it remains vital for healthcare providers to stay up-to-date with newer therapeutic options.
本综述旨在介绍2021年获得美国食品药品监督管理局批准的靶向抗癌药物临床试验的最新结果，并反映实体恶性肿瘤治疗格局的变化。
2021年的新批准和补充批准信息从美国食品药品监督管理局（Drugs@FDA）的官方网页检索。本综述不包括仿制药、生物类似药、成像和诊断试剂的批准。
本综述纳入了2021年美国食品药品监督管理局批准的10种新药（用于11个适应症）和10种已批准药物（用于21个适应症）。新批准主要与治疗罕见病有关。此外，三分之一的补充批准用于新辅助或辅助治疗，每个肿瘤部位的适应症数量如下：胃肠道（7个）、泌尿生殖系统（5个）、皮肤（3个）、肺（2个）、乳腺（2个）、甲状腺（1个）和子宫颈（1个）。
靶向癌症治疗在治疗恶性疾病方面比以往任何时候都更加重要。由于靶向抗癌药物的批准为患者提供了可能性，并且预计这一趋势在未来将持续，医疗保健提供者了解最新的治疗选择仍然至关重要。
