Dabrafenib Tafinlar indications

Dabrafenib is an anti-tumor drug. Dabrafenib was developed and produced by the Swiss pharmaceutical company Novartis. It was approved for marketing by the State Food and Drug Administration of China on December 12, 2019.

Dabrafenib indications are as follows:

1.1BRAF V600EMutation-positive unresectable or metastatic melanoma

Dabrafenib is indicated as a single agent for the treatment of patients with unresectable or metastatic melanoma that has been tested in a FDA-approved trial for the BRAF V600E mutation.

2.BRAF V600Eor V600KMutation-positive unresectable or metastatic melanoma

Dabrafenib in combination with trametinib is indicated for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations detected in FDA-approved trials.

3.BRAF V600EorV600KAdjuvant therapy for mutation-positive melanoma

Dabrafenib in combination with trametinib is indicated for the adjuvant treatment of patients with melanoma whose BRAF V600E or V600K mutations have been detected in FDA-approved trials and who have lymph node involvement after complete resection.

4.BRAF V600EMutation-positive metastatic non-small cell lung cancer

Dabrafenib in combination with trametinib for the treatment of metastatic non-small cell lung cancer with FDA-approved trials detecting BRAF V600E mutations(NSCLC)Patients.

5.BRAF V600EMutation-positive locally advanced or metastatic anaplastic thyroid cancer

Dabrafenib in combination with trametinib is indicated for the treatment of patients with BRAF V600E mutated locally advanced or metastatic anaplastic thyroid cancer(ATC) for whom no satisfactory locoregional treatment options are available.

6. BRAF V600EMutation-positive unresectable or metastatic solid tumors

Dabrafenib in combination with trametinib is indicated for the treatment of adult and pediatric patients 1 years of age and older with BRAF V600E mutated unresectable or metastatic solid tumors who have progressed after prior therapy and for whom no satisfactory alternative treatment options are available. This indication received accelerated approval based on overall response rate (ORR) and duration of response (DoR). Continued approval for this indication may be contingent upon verification and characterization of clinical benefit in confirmatory trials.

7.BRAF V600EMutation-positive low-grade glioma

Dabrafenib in combination with trametinib is indicated for the treatment of pediatric patients 1 years of age and older with BRAF V600E mutated low-grade glioma(LGG) who require systemic therapy.

Usage restrictions:

Due to known inherent resistance to BRAFinhibition, dabrafenib is not suitable for use in the treatment of patients with colorectal cancer. Dabrafenib is not indicated for the treatment of patients with wild-type BRAFsolid tumors. If you want to get more high-quality information, you can contact Yaode , Yaode will do its best to learn more about high-quality overseas drugs for you.