The United States Food and Drug Administration recently approved Mekinist, in combination with Tafinlar, to treat patients with advanced melanoma that is either late-stage, or cannot be removed with surgery. According to the FDA, Mekinist and Tafinlar are used in combination to block signaling in different sites of the same molecular pathway that promote cancer cell growth.
“Mekinist and Tafinlar are the first drugs approved for combination treatment of melanoma,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “Their development for combinat
ion use is based on the strong understanding of the biological pathways of the disease. This approval illustrates the value of continuing to study drugs in combination for clinical development.”
Avella Specialty Pharmacy is your pharmacy partner for these newly released medication. Avella is here to help oncology patients with their complex medication treatments including continual support and education. Our pharmacists and clinical support teams work to maintain a continuum of care between the oncology office and the patient. This ensures we are in constant communication with the patient and the health care providers to ensure safe, efficient and quality care.
Our pharmacists closely monitor dosages and side effects of cancer medications, are able to address insurance problems, including Medicare and secondary insurance billing, and are familiar with patient assistance programs including manufacturer programs.
We invite you to learn more about Avella, or get in touch with your local representative:
MEKINIST is a kinase inhibitor indicated as a single agent and in combination with dabrafenib for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations as detected by an FDA-approved test. The use in combination is based on the demonstration of durable response rate. Improvement in disease-related symptoms or overall survival has not been demonstrated for MEKINIST in combination with dabrafenib.Limitation of use: MEKINIST as a single agent is not indicated for treatment of patients who have received prior BRAF-inhibitor therapy. Mekinist™ (trametinib) for use in combination with Tafinlar® (dabrafenib) for the treatment of patients with unresectable melanoma (melanoma that cannot be removed by surgery) or metastatic melanoma (melanoma which has spread to other parts of the body) with BRAF V600E or V600K mutations. These mutations must be detected by an FDA-approved test. Tafinlar is not indicated for treatment of patients with wild-type BRAF melanoma. Full prescribing information is available at www.mekinist.com
TAFINLAR is a kinase inhibitor indicated as a single agent for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation as detected by an FDA-approved test. TAFINLAR in combination with trametinib is indicated for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations as detected by an FDA-approved test. The use in combination is based on the demonstration of durable response rate. Improvement in disease-related symptoms or overall survival has not been demonstrated for TAFINLAR in combination with trametinib. Limitation of Use:TAFINLAR is not indicated for treatment of patients with wild-type BRAF melanoma. Full prescribing information is available at www.tafinlar.com