European Commission approves two options for treating HNSCC patients in Mercadon Keytruda
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Last Update: 2020-06-07
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Source: Internet
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Author: User
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recently, Mersadon announced that the European Commission (EC) has approved two options for Keytruda (Corida, generic name: pembrolizumab, Pablozumab), a first-line treatment of patients with metastatic or non-reprecentable recurrent head and neck squamous cell carcinoma (HNSCC)As a single-drug therapy or in combination with a commonly used chemotherapy (platinum -5-fluoromyquine (5-FU) for patients with tumor expression PD-L1 (combined positive score of CPS)About Keytrudain the United States, Keytruda was approved in June this year by theFDA(http://approved 2 new indications, first-line treatment of metastatic or non-reprecable REcurrent HNSCC patients, specifically:(1) as a single-drug therapy, For patients with tumor expression PD-L1 (combined positive score of CPS) and(2) combined with a commonly used chemotherapy regimen (platinum - 5-fluoromyquine (5-FU) regardless of the expression status of the patient's tumor PD-L1This approval makes Keytruda the first anti-PD-1 therapy approved for first-line treatment for metastatic or non-reprecable recurrent HNSCC patients, and the first anti-PD-1 therapy in such patients to significantly improve total survival (OS) in a statistically significant improvementFor keynote-048this approval is based on data from key Phase III clinical studies keynote-048 (NCT02358031)KEYNOTE-048 is a random, open label study designed to assess the efficacy and efficacy of Keytruda as a single-drug therapy or as a combination of combination therapy with platinum (cisplatin or caucin) and 5-fluoromyache chemotherapy in relation to the current HNSCC first-line treatment standard care regimenitis EXTREME (Erbitux?cetuximab, sitoxaxipro-resistant) and platinum-c) and 5-fluoroureuriche combination therapyThe results showed that keytruda was treated as a single-drug therapy (HR -0.74.95% CI: 0.61-0.9) in the group of patients with head and neck cancer with tumor expression PD-L1 (CPS-1) compared to THE first-line standard treatment plan, EXTREME0, p.00133) and combined chemotherapy (HR?0.65(95% CI: 0.53-0.80) and p-0.00002) significantly extended the total lifetime (OS)
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