Merck: FDA to review new dosing options for Keytruda
(CercleFinance.com) - Merck said U.
S. health regulators are set to review six supplemental applications to update the dosing frequency for its blockbuster cancer drug Keytruda.
Merck is seeking FDA approval of an every-six-weeks dose infused over 30 minutes for indications in melanoma, classical Hodgkin lymphoma, primary mediastinal large B-cell lymphoma, gastric cancer, hepatocellular carcinoma and Merkel cell carcinoma.
If approved by the FDA, the every-six-weeks dose would be available for use in adults, in addition to the currently approved dose of 200 mg every three weeks infused over 30 minutes.
The FDA has set a target action date of February 2020.
Copyright (c) 2019 CercleFinance.com. All rights reserved.
S. health regulators are set to review six supplemental applications to update the dosing frequency for its blockbuster cancer drug Keytruda.
Merck is seeking FDA approval of an every-six-weeks dose infused over 30 minutes for indications in melanoma, classical Hodgkin lymphoma, primary mediastinal large B-cell lymphoma, gastric cancer, hepatocellular carcinoma and Merkel cell carcinoma.
If approved by the FDA, the every-six-weeks dose would be available for use in adults, in addition to the currently approved dose of 200 mg every three weeks infused over 30 minutes.
The FDA has set a target action date of February 2020.
Copyright (c) 2019 CercleFinance.com. All rights reserved.