European Commission approves Merck KEYTRUDA as a HNSCC treatment
Category: #health  By Saipriya Iyer  Date: 2019-11-22
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European Commission approves Merck KEYTRUDA as a HNSCC treatment

Merck, a renowned American pharmaceutical firm and one of the largest pharmaceutical companies in the world reportedly announced the approval of KEYTRUDA by European Commission.

Merck anti-PD-1 therapy, has been approved in combination with 5-fluorouracil (5-FU) and platinum chemotherapy or as a monotherapy, for the first-line therapy of patient suffering from unresectable or metastatic recurrent HNSCC (head and neck squamous cell carcinoma) whose tumors express PD-L1 ([CPS] ≥1 combined positive score).

The KEYTRUDA approval enables marketing of the same as monotherapy as well as combination regimen across all 28 EU member states and also in Norway, Iceland and Lichtenstein.

The European Commission approved KEYTRUDA on the basis of outcomes from pivotal KEYNOTE-048 Phase 3 study, in which KEYTRUDA, in comparison to the standard therapy (cetuximab with cisplatin plus 5-FU or carboplatin), showcased a substantial improvement in OS (overall survival) as monotherapy and together with chemotherapy in people whose tumors showed PD-L1 (CPS ≥1).

Professor Kevin Harrington, the KEYNOTE-048 investigator, consultant clinical oncologist of The Royal Marsden NHS Foundation Trust, professor of the biological cancer therapies in The Institute of Cancer Research at London stated that this tumor is particularly debilitating as it could affect a patient’s appearance by being conspicuously visible and impact their day-to-day functions like speaking and eating.

Understanding the heavy demand for new therapies, the company is encouraged by the KEYTRUDA approval in the EU. It would now enable patients to receive treatment with immunotherapy earlier during the course of the treatment.   

Vice President of clinical research at Merck Research Laboratories, Dr. Jonathan Cheng stated that KEYTRUDA has now become the first-in-class anti-PD-1 therapy option within the first setting for unresectable or metastatic recurrent HNSCC. This cancer has been treated in the same manner across the EU for over a decade.

Cheng further added that European Commission approval highlights the company’s commitment to revolutionizing the way this fatal disease is treated across the world.

Source credit: https://www.mrknewsroom.com/news-release/oncology/european-commission-approves-two-new-regimens-mercks-keytruda-pembrolizumab-fi



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Saipriya Iyer

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Saipriya Iyer

Saipriya Iyer develops content for Market Size Forecasters, Algosonline, and myriad other platforms. A computer engineer by profession, she ventured into the field of writing for the love of playing with words. Having had a previous experience of 3 years under her bel...

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