(Breast Cancer) FDA Approves Keytruda as Neoadjuvant and Adjuvant Therapy
Medical Supporter — إشعار معلوماتي
هذه المقالة ملخص لمعلومات طبية دولية وليست نصيحة طبية، ولا يمكن أن تحل محل تشخيص طبيبك المعالج أو خطة العلاج. المعلومات المعروضة مجمّعة من منشورات عامة وبيانات رسمية لكبرى المؤسسات الطبية اليابانية؛ وتختلف ملاءمة ونتائج أي علاج من مريض لآخر ويجب أن يقيّمها طبيب مؤهل لكل حالة على حدة.
- August 6, 2021
- Reading time: 1 minute
On July 26, 2021, the US Food and Drug Administration (FDA) approved pembrolizumab (Keytruda) plus chemotherapy as neoadjuvant therapy followed by single-agent Keytruda as adjuvant therapy for early-stage triple-negative breast cancer (TNBC). Additionally, in November 2020, the FDA had previously granted accelerated approval for Keytruda plus chemotherapy for patients with locally recurrent unresectable or metastatic TNBC whose tumors express PD-L1 (CPS ≥10).
Trial Design: KEYNOTE-522
This approval was based on KEYNOTE-522 (NCT03036488), a multicenter, double-blind trial that randomized previously untreated early-stage TNBC patients (N=1,174) in a 2:1 ratio to:
- Keytruda group: Keytruda + chemotherapy as neoadjuvant therapy, followed by single-agent Keytruda as adjuvant therapy
- Placebo group
Primary endpoints: Pathologic complete response (pCR) rate and event-free survival (EFS).
Efficacy Results
- pCR rate: Keytruda group 63% / Placebo group 56%
- Event-free survival: Keytruda group improved by 16% / Placebo group improved by 24%
Safety Profile
Adverse events occurring in ≥20% of Keytruda-treated patients: fatigue, asthenia, nausea, constipation, diarrhea, decreased appetite, rash, vomiting, cough, dyspnea, fever, alopecia, peripheral neuropathy, stomatitis, headache, weight loss, abdominal pain, arthralgia, myalgia, and insomnia.
Recommended Dosing
For TNBC patients: Keytruda 200 mg every 3 weeks or 400 mg every 6 weeks. Duration: Keytruda + chemotherapy for 24 weeks (neoadjuvant); single-agent Keytruda for 27 weeks (adjuvant).
- Clinical trial drug
- Immunotherapy
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هل تفكر في تلقّي العلاج في اليابان؟ هل تحتاج إلى معلومات ومساعدة؟
نساعدك في تنظيم المعلومات اللازمة للسفر الطبي إلى اليابان، والتواصل مع المؤسسات الطبية اليابانية، وترتيب استشارة رأي ثانٍ.الاستشارة الأولى مجانية؛ سيساعدك المستشار على توضيح الخطوات التالية.
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