Expanded Indication for Briviact in Seizure Treatment
August 30, 2021FDA Requires New Warnings on Drugs in the JAK Inhibitors Class
September 1, 2021August 31, 2021 – Keytruda® (pembrolizumab) has been U.S. FDA approved as a first-line treatment for locally advanced or metastatic urothelial carcinoma (UC) in patients who are not eligible for any platinum- containing chemotherapy.
- This action converts a conditional accelerated approval for the indication into full approval.
However, it reduces the indication's original scope.
- The indication originally included treatment of patients who had locally advanced or metastatic UC and were positive for PD-L1 according to an FDA-approved test but were not eligible for cisplatin-containing chemotherapy.
- In a clinical study required under the conditional accelerated approval, Keytruda did not meet overall survival or progression-free survival requirements for patients who were ineligible for cisplatin-containing chemotherapy.
- Keytruda's recommended dosing for UC is 200mg given via intravenous infusion once every three weeks or 400mg given once every six weeks. Treatment under this indication should continue until disease progression or unacceptable toxicity occur, or for up to a maximum of 24 months.
- Manufactured by Merck and originally FDA approved in 2014, Keytruda currently holds 30 indications to treat cancer.