Dabrafenib Mesylate

China [CN]

1. Core Uses

Approved Indications (all require BRAF V600 mutation positivity):

Unresectable/metastatic melanoma (monotherapy or in combination with Trametinib)

Non-small cell lung cancer (NSCLC) (in combination with Trametinib)

Locally advanced/metastatic anaplastic thyroid carcinoma (ATC) (in combination with Trametinib)

Pediatric low-grade glioma (LGG) (≥1 year old, in combination with Trametinib) NCI

Mechanism: Selectively blocks mutated BRAF kinase activity, inhibiting the downstream MEK/ERK signaling pathway, and blocking tumor cell proliferation and survival; combination with Trametinib (MEK inhibitor) can overcome resistance and prolong PFS.

2. Key Clinical Information

Dosage Form: Oral hard capsules (50mg, 75mg, as dabrafenib)

Dosage and Administration: 150mg twice daily (1 hour before meals / 2 hours after meals), in combination with Trametinib 2mg once daily

Core Advantages:

High selectivity: Inhibits only BRAF V600 mutants, with minimal effect on wild-type BRAF, resulting in manageable side effects.

Synergistic effect: When used in combination with Trametinib, it significantly improves PFS and OS in melanoma and NSCLC patients.

Multi-cancer coverage: Wide range of approved indications, meeting significant clinical needs.