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The Committee for Medicinal Products for Human Use ( CHMP ) of the European Medicines Agency ( EMA ) has adopted a positive opinion recommending approval of two regimens of Keytruda ( Pembrolizumab ), anti-PD-1 therapy, for the first-line treatment of metastatic or unresectable recurrent head and neck squamous cell carcinoma ( HNSCC ).

Keytruda, as monotherapy or in combination with Platinum and 5-Fluorouracil ( 5-FU ) chemotherapy, is recommended in patients whose tumors express PD-L1 ( combined positive score [ CPS ] greater than or equal to 1 ).
This recommendation is based on data from the pivotal phase 3 KEYNOTE-048 trial, in which Keytruda, as monotherapy and in combination with chemotherapy, has demonstrated a significant improvement in overall survival, compared with standard treatment ( Cetuximab with Carboplatin or Cisplatin plus 5-FU ), in these patient populations.

Head and neck cancer describes a number of different tumors that develop in or around the throat, larynx, nose, sinuses and mouth.
Most head and neck cancers are squamous cell carcinomas that begin in the flat, squamous cells that make up the thin surface layer of the structures in the head and neck.
Two substances that greatly increase the risk of developing head and neck cancer are tobacco and alcohol.
It is estimated that there were more than 705,000 new cases of head and neck cancer diagnosed and over 358,000 deaths from the disease worldwide in 2018.
In Europe, it is estimated that there were more than 146,000 newly diagnosed cases of head and neck cancer and around 66,000 deaths from the disease in 2018.

Pembrolizumab is an anti-PD-1 therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells.
Pembrolizumab is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells. ( Xagena )

Source: Merck ( MSD ), 2019

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