FDA Approval Summary: Pembrolizumab for Neoadjuvant and Adjuvant Treatment of Patients with High-Risk Early-Stage Triple-Negative Breast Cancer
| العنوان: | FDA Approval Summary: Pembrolizumab for Neoadjuvant and Adjuvant Treatment of Patients with High-Risk Early-Stage Triple-Negative Breast Cancer |
|---|---|
| المؤلفون: | Mirat Shah, Christy L. Osgood, Anup K. Amatya, Mallorie H. Fiero, William F. Pierce, Abhilasha Nair, Jonathan Herz, Kim J. Robertson, Bronwyn D. Mixter, Shenghui Tang, Richard Pazdur, Julia A. Beaver, Laleh Amiri-Kordestani |
| المصدر: | Clinical Cancer Research. 28:5249-5253 |
| بيانات النشر: | American Association for Cancer Research (AACR), 2022. |
| سنة النشر: | 2022 |
| مصطلحات موضوعية: | Cancer Research, Oncology |
| الوصف: | On July 26, 2021, the FDA granted approval to pembrolizumab in combination with chemotherapy for neoadjuvant treatment and then continued as a single agent for adjuvant treatment following surgery for patients with high-risk, early-stage triple-negative breast cancer. Approval was based on results from KEYNOTE-522, an ongoing randomized (2:1) trial evaluating pembrolizumab or placebo in combination with chemotherapy for neoadjuvant treatment and then as a single agent for adjuvant treatment. The co-primary endpoints were pathological complete response (pCR) rate and event-free survival (EFS). The trial demonstrated an improvement in pCR and EFS in the pembrolizumab arm compared with the control arm. The number of patients who experienced an EFS event was 123 (16%) and 93 (24%), respectively [HR: 0.63, 95% confidence interval (CI), 0.48–0.82, P = 0.00031]. Patients on the pembrolizumab arm experienced EFS benefit regardless of tumor PD-L1 status. The absolute pCR rate improvement with the addition of pembrolizumab was 7.5% (95% CI, 1.6–13.4). Among patients receiving pembrolizumab, 44% experienced an immune-related adverse reaction. This article summarizes FDA's review of pembrolizumab and the data supporting the favorable benefit–risk assessment. |
| تدمد: | 1557-3265 1078-0432 |
| DOI: | 10.1158/1078-0432.ccr-22-1110 |
| URL الوصول: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::1426031d7067e51262fb0af0bf1bd72e https://doi.org/10.1158/1078-0432.ccr-22-1110 |
| رقم الانضمام: | edsair.doi.dedup.....1426031d7067e51262fb0af0bf1bd72e |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 15573265 10780432 |
|---|---|
| DOI: | 10.1158/1078-0432.ccr-22-1110 |