Posts

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.

Ribociclib FDA label updated to include pre- and perimenopausal women

FDA approves dabrafenib plus trametinib for anaplastic thyroid cancer with BRAF V600E mutation

 

  • FDA approves dabrafenib plus trametinib for anaplastic thyroid cancer with BRAF V600E mutation. More Information. May 4, 2018.
Ribociclib FDA label updated to include pre- and perimenopausal women

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. 

Ribociclib FDA label updated to include pre- and perimenopausal women

Vemurafenib FDA approved for treatment of Erdheim-Chester Disease with BRAF V600 mutation

On 6 November 2017, the FDA granted regular approval to vemurafenib (Zelboraf®, Roche) for the treatment of patients with Erdheim-Chester Disease (ECD) harbouring a BRAF V600 mutation.

Ribociclib FDA label updated to include pre- and perimenopausal women