The purpose of this Cohort Treatment Plan is to allow access to trametinib (monotherapy or in combination) and dabrafenib (monotherapy or in combination) for eligible patients diagnosed with metastatic melanoma BRAF mutation-positive.
The patient's Treating Physician should follow the suggested treatment guidelines and comply with all local health authority regulations. The requesting Treating Physician submitted a request for access to drug (often referred to as Compassionate Use) to Novartis which was reviewed and approved by the medical team experienced with the drug and indication. This program will provide access to patients until: - All participating countries have received marketing authorization and product is commercially available and accessible to all participating patient(s) or - Alternative treatment options are available and/or - In case of changes in the safety profile or a lack of overall efficacy of the product.
Drug: Dabrafenib and Trametinib
The starting dose of the combination treatment will be administered as follows:
Dabrafenib, 150 mg, twice daily (BID);
Trametinib, 2.0 mg, once daily (QD)
If a dose reduction below 50 mg BID for dabrafenib is required, dabrafenib will be permanently discontinued, but the patient will be allowed to continue trametinib.
If a dose reduction below 1.0 mg once daily for trametinib is required, then trametinib will be permanently discontinued, but the patients will be allowed to continue dabrafenib.
This program is no longer accepting new patients