On January 10, 2014 the FDA announced the accelerated approval for a drug combination consisting of Trametinib (Mekinist) and Dabrafenib (Tafinlar) to treat patients with unresectable melanoma. Patients approved to receive this treatment must have the BRAF V600E mutations or BRAF V600K mutations of metastatic melanoma. Additionally, patients must have the BRAF V600E or V600K[…]
Accelerated Approval for Trametinib and Dabrafenib Combination
Chemotherapeutic / Anti-Neoplastic, Drug Research & Development API, FDA Approved 2014 Tags: 1195765-45-7Dabrafenib and TrametinibMekinistmetastatic melanomaTafinlarTrametinibunresectable melanoma Jan 29, 2014
Dabrafenib Named Breakthrough Therapy for Lung Cancer
Chemotherapeutic / Anti-Neoplastic, Drug Research & Development API, FDA Breakthrough Therapy Status Tags: 1195765-45-7Dabrafenib and TrametinibTafinlarunresectable melanoma Jan 16, 2014
On January 14, 2014 the FDA declared a Breakthrough Therapy designation for Dabrafenib, also known as the brand name Tafinlar as a single agent to treat certain types of lung cancer, specifically for the treatment of metastatic BRAF V600E mutation-positive non-small cell lung cancer. The target patient population should have already previously received one line[…]
Priority Review Status Announced for Unresectable Melanoma Drugs Dabrafenib and Trametinib
Chemotherapeutic / Anti-Neoplastic, Drug Research & Development API Tags: 1195765-45-7Dabrafenib and TrametinibMekinistmetastatic melanomaTafinlarTrametinibunresectable melanoma Sep 23, 2013
On September 16, 2013 GlaxoSmithKline announced that two of their new drugs, Tafinlar {Dabrafenib} and Mekinist {Trametinib} were given priority review status from the FDA. This news is extremely exciting for researchers, practitioners and especially patients who are suffering from metastatic melanoma. As the leading cause of death from skin disease, metastatic or unresectable melanoma[…]
Dabrafenib and Trametinib Bring Hope for Patients with Metastatic Melanoma
Chemotherapeutic / Anti-Neoplastic, Drug Research & Development API Tags: Dabrafenib and TrametinibMekinistmetastatic melanomaTafinlarunresectable melanoma Jun 14, 2013
Patients with metastatic melanoma received encouraging news on May 29, 2013 with the FDA approval of two new treatments. Dabrafenib, known as the brand name Tafinlar and Trametinib, known as the brand name Mekinist were both approved at the end of May to treat metastatic or unresectable melanoma. While both of these powerhouse medications Dabrafenib[…]