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Dabrafenib, sold under the brand name Tafinlar among others, is an anti-cancer medication used for the treatment of cancers associated with a mutated version of the gene BRAF. [2] Dabrafenib acts as an inhibitor of the associated enzyme B-Raf, which plays a role in the regulation of cell growth .
Pralsetinib was approved for medical use in the United States in September 2020. [14] [15] Dabrafenib and trametinib have been approved as tissue-agnostic drugs for solid tumors that are B-RAF positive. [16] Tissue-agnostic cancer drugs that are under development as of May 2022 include Selitrectinib (Loxo-195) and anti-ERBB3 antibodies. [7]
On 1 May 2018, the FDA approved the combination dabrafenib/trametinib as an adjuvant treatment for BRAF V600E-mutated, stage III melanoma after surgical resection based on the results of the COMBI-AD phase 3 study, [13] making it the first oral chemotherapy regimen that prevents cancer relapse for node positive, BRAF-mutated melanoma. [14]
Glasdegib was approved for medical use in the United States in December 2018. [5] [6] [9] [10] [11]FDA approval was based on a multicenter, open-label, randomized study (BRIGHT AML 1003, NCT01546038) that included 115 subjects with newly-diagnosed AML who met at least one of the following criteria: a) age 75 years or older, b) severe cardiac disease, c) baseline Eastern Cooperative Oncology ...
(Reuters) -The U.S. Food and Drug Administration granted accelerated approval to French drugmakers Ipsen and Genfit's drug for a chronic inflammatory liver disease, Iqirvo, the companies said on ...
In combination with palbociclib and fulvestrant for the treatment of adults with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth-factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, as detected by an FDA-approved test, following recurrence on or after completing adjuvant ...
(Reuters) -The U.S. Food and Drug Administration on Monday delayed traditional approval for Liquidia Corp's inhaled drug for types of lung disorders, and allowed only tentative clearances, sending ...
After good results in 2014, the combination was submitted to the European Medical Agency and the US Food and Drug Administration for marketing approval. [21] In January 2015, trial results compared vemurafenib with the combination of dabrafenib and trametinib for metastatic melanoma. [22]
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