FDA Approves Priority Review of Merck's Zolinza (Vorinostat)
WHITEHOUSE STATION, New JerseyFDA has granted priority review status to Merck's New Drug Application for Zolinza (vorinostat, also known as suberoylanilide hydroxamic acid or SAHA) for the treatment of advanced cutaneous T-cell lymphoma (CTCL). A pivotal phase IIb trial showed activity in CTCL patients who had failed a median of three previous therapies. Zolinza is potentially the first in a new class of therapies, the histone deacetylase inhibitors.
FDA Approves Encorafenib/Cetuximab Plus mFOLFOX6 for Advanced BRAF V600E+ CRC
December 20th 2024The FDA has granted accelerated approval to encorafenib in combination with cetuximab and mFOLFOX6 for patients with metastatic colorectal cancer with a BRAF V600E mutation, as detected by an FDA-approved test.