What is dabrafenib/dabrafenib and what are its indications?

Dabrafenib is a kinase inhibitor indicated for the treatment of melanoma, non-small cell lung cancer, thyroid cancer, solid tumors, and low-grade gliomas with BRAF V600 mutations. Dabrafenib is an inhibitor of some mutant BRAF kinases, including the BRAF V600E and V600K mutations. Dabrafenib works by blocking the action of the abnormal BRAF protein in people with BRAF mutations, helping to slow the growth and spread of cancer. Dabrafenib is currently provided to patients in the form of capsules, which need to be taken orally twice daily, at least one hour before meals or at least 2 hours after meals. Its indications include the following conditions:

1. As a single agent for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutations detected in a U.S. Food and Drug Administration (FDA)approved test.

2. Or combined with Trametinib (Trametinib) for the treatment of:

(1) Treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations detected by an FDA-approved test; Adjuvant therapy for such patients based on an FDA-approved test with lymph node involvement after complete resection.

(2) Treatment of patients with metastatic non-small cell lung cancer (NSCLC) with BRAF V600E mutations detected in FDA-approved tests;

(3) Treatment of patients with locally advanced or metastatic anaplastic thyroid cancer (ATC) who have BRAF V600E mutation and no satisfactory locoregional treatment options.

(4) Treatment of adult and pediatric patients 6 years of age and older with unresectable or metastatic BRAF V600E-mutant solid tumors who have progressed after prior therapy and for whom satisfactory alternative treatment options are not available.

(5) Treatment of pediatric patients 1 year of age and older with BRAF V600E-mutated low-grade glioma (LGG) who require systemic therapy.