Product Name: LuciTram
Manufacturer: Lucius Pharmaceuticals (Laos) Co., Ltd.
English Name: Trametinib Tablets
Approval Number: 09 L 1010/23 Indications LuciTram is a kinase inhibitor (MEK inhibitor) indicated for the treatment of patients with specific BRAF V600 mutations, as detected by an FDA-approved test. As monotherapy (single agent):
- Treatment of BRAF inhibitor treatment-naïve patients with unresectable or metastatic melanoma harboring BRAF V600E or V600K mutations.
In combination with dabrafenib:
- Treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations.
- Adjuvant treatment (after complete resection) of patients with Stage III melanoma with BRAF V600E or V600K mutations and lymph node involvement.
- Treatment of patients with metastatic non-small cell lung cancer (NSCLC) with BRAF V600E mutation.
- Treatment of patients with locally advanced or metastatic anaplastic thyroid cancer (ATC) with BRAF V600E mutation and no satisfactory locoregional treatment options.
- Treatment of adult and pediatric patients (1 year of age and older) with unresectable or metastatic solid tumors with BRAF V600E mutation who have progressed following prior treatment and have no satisfactory alternative treatment options.
(This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials.) - Treatment of pediatric patients (1 year of age and older) with low-grade glioma (LGG) with BRAF V600E mutation requiring systemic therapy.
Reviews
There are no reviews yet.