Accelerated Approval for Trametinib and Dabrafenib Combination

Accelerated Approval for Trametinib and Dabrafenib Combination

Dabrafenib-and-Trametinib-Accelerated-ApprovalOn 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 mutations detected through an approved test sponsored by the FDA. Even with these stringent treatment requirements, the opportunity for an extended life for patients with this virulent form of terminal melanoma is hopeful.

BRAF mutationsThe FDA approved this dynamic drug combo based on a data from Phase 1 and 2 studies. The response rate and average duration of response proved to be encouraging, with 76 percent of patients treated with the Trametinib/Dabrafenib combination demonstrating a positive response rate. In comparison, a 54 percent response rate was shown by patients who received Dabrafenib only. The dosages for both Phase 1 and 2 studies were 150 milligrams of Trametinib and 2 milligrams of Dabrafenib daily.  For the patient group treated with the melanoma combination there was an average duration of response of 10.5 months, compared to only 5.6 months duration of response for patients who were administered Dabrafenib alone.

The FDA’s Accelerated Approval program, as well as a Priority Review designation pivoted the Trametinib and Dabrafenib combination to the forefront of targeted treatments for patients with metastatic melanoma. A current Phase 3 trial, coined “Combi-D” or “MEK115306” is underway evaluating the clinical benefit of this formidable drug combination. The FDA accelerated approval is now based on the results from the Phase 3 trial. The ability of research and development to combine effective anti-cancer agents, like Dabrafenib and Trametinib, to specifically target the growth of cancer cells is exciting.

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

Products currently covered by valid US Patents are offered for R&D use in accordance with 35 USC 271(e) +A13(1). Any patent infringement and resulting liability is solely at buyer risk.

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LGM Pharma Acquires CDMO

On July 27, 2020, LGM Pharma announced its acquisition of the formulation development and drug product contract manufacturing business of Nexgen Pharma, Inc. As a result, you will notice our new logo and visuals throughout the website. We’re working on updates to reflect the exciting, expanded CDMO capabilities and services we now can offer you.

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