Merck: positive opinion for Keytruda in Europe
(CercleFinance.com) - Merck announced on Tuesday that it has received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) to update the package insert for its anti-cancer drug Keytruda.
The recommendation will enable the US pharma group to add to the dosing regimen data from a Phase 3 clinical trial evaluating Keytruda in the first-line treatment of selected patients with advanced or metastatic urothelial carcinoma.
While the trial did not meet its primary endpoint, the CHMP found that the drug had a favourable risk/benefit profile for this indication and that it was up to doctors to decide on its use on an individual basis.
This green light comes a day after the FDA refused to approve Merck's application for the use of Keytruda in early-stage metastatic triple-negative breast cancer.
Finally, Merck announced on Tuesday that it has completed the acquisition of Alydia Health, a specialist in post-partum haemorrhage, on behalf of its women's health subsidiary Organon - which is soon to be split - for 240 million dollars.
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The recommendation will enable the US pharma group to add to the dosing regimen data from a Phase 3 clinical trial evaluating Keytruda in the first-line treatment of selected patients with advanced or metastatic urothelial carcinoma.
While the trial did not meet its primary endpoint, the CHMP found that the drug had a favourable risk/benefit profile for this indication and that it was up to doctors to decide on its use on an individual basis.
This green light comes a day after the FDA refused to approve Merck's application for the use of Keytruda in early-stage metastatic triple-negative breast cancer.
Finally, Merck announced on Tuesday that it has completed the acquisition of Alydia Health, a specialist in post-partum haemorrhage, on behalf of its women's health subsidiary Organon - which is soon to be split - for 240 million dollars.
Copyright (c) 2021 CercleFinance.com. All rights reserved.