Priority Review Status Announced for Unresectable Melanoma Drugs Dabrafenib and Trametinib


Dabrafenib-and-Trametinib-Priority-Review-StatusOn 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 will affect almost 77,000 Americans in 2013. The advent of both Dabrafenib and Trametinib as single or as a potential combination treatment for patients with the most virulent form of skin cancer has offered a new hope for treatment and life extension.

Dabrafenib is currently approved to treat patients with melanoma whose tumors have the BRAF V600E gene mutation. As a BRAF inhibitor, Dabrafenib has proven to work alongside Trametinib, which is approved to treat patients whose tumors express both the BRAF V600E or BRAF V600K gene mutations. Roughly half of all patients diagnosed with metastatic melanoma have a BRAF gene mutation. While each of these formidable medications will be looked at by the FDA as individual agents, the combination treatment of these drugs is being investigated. The recent approval of the THxID BRAF test is another boon for individualized and specialized treatment for patients with unresectable melanoma, as researchers can now target patient treatment for successful results.

Significant data from studies using both Dabrafenib and Trametinib have shown efficacy when treating patients with the BRAF gene mutations. One particular study involved 250 patients with metastatic melanoma and the BRAF gene mutation, who received Dabrafenib alongside the chemotherapeutic agent Dacarbazine. Of these patients, tumor growth was delayed by 2.4 months, as compared to the patients who were administered Dacarbazine only. Adverse effects did occur in a small number of patients, including fevers, hypotension and increased blood sugar levels. Patients who are diabetic should be closely monitored while taking Dabrafenib. The majority of patients who received Dabrafenib experienced mild side effects, like hyperkeratosis, or a thickening of their skin, headaches and hair loss.

 melanoma development

Positive data emerged from studies involving Trametinib as well. One such study involved 322 patients who had the BRAF gene mutation and unresectable melanoma. The patient population who received Trametinib had a delay in tumor growth of 3.3 months. Compared to the patients in this study who received standard chemotherapeutic care, Trametinib offered clinically better, effective and tolerable results. A minor number of patients experienced serious adverse effects, which included lung inflammation and skin infections. The common side effects were limited to diarrhea, mild skin rashes and peripheral edema.

LGM Pharma provides the API’s Dabrafenib CAS# 1195765-45-7 and Trametinib CAS# 871700-17-3 for research and development purposes. Clients can be assured of continuous support throughout the R&D process, as well as quality API products.

 

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