Posts

U.S. FDA Approved Immune-Checkpoint Inhibitors Updated 19-Jul-2018

Since 2011, when the United States Food and Drug Administration (U.S. FDA) approved ipilimumab (Yervoy®) for malignant melanoma, several immune-checkpoint inhibitors have been granted marketing authorisation. Do you know all the indications? MediPaper made an overview of all the U.S. FDA approved immune-checkpoint inhibitors and other U.S. FDA approved immunotherapies.

Combination encorafenib plus binimetinib for unresectable/metastatic BRAF V600E or V600K-positive melanoma FDA approved

On June 27th, the FDA approved Array Biomarpharma's combination encorafenib (BRAFTOVI®) plus binimetinib (and MEKTOVI®) for patients with unresectable or metastatic melanoma harbouring a BRAF V600E or V600K mutation detected by an FDA-approved test.

Adjuvant dabrafenib plus trametinib FDA approved for BRAF V600E or V600K melanoma

The FDA granted regular approval to dabrafenib (Tafinlar®, Novartis) and trametinib (Mekinist®, Novartis) in combination for the adjuvant treatment of patients with melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test, and involvement of lymph node(s), following complete resection.