The specialty pharmacy will give patients access to this important new FDA-approved combination therapy for patients with advanced BRAF melanoma.
PHOENIX- Avella has announced that it will distribute BRAFTOVITM (encorafenib and MEKTOVI® (binimetinib), a combination therapy recently FDA approved for patients for the treatment of patients with unresectable or metastatic melanoma with a BRAFV600E or BRAFV600K mutation, as detected by an FDA-approved test.
Metastatic melanoma is the most serious, life-threatening type of skin cancer and is associated with low survival rates overall. Approximately 9,000 people are expected to die of melanoma in 2018. There are about 200,000 new cases of melanoma diagnosed worldwide each year, and approximately half of these have BRAF mutation.
A gene mutation is an abnormal alteration in the DNA sequence that makes up a gene. Many new cancer therapies specifically target cells that have certain gene mutations rather than attacking all rapidly-dividing cells. This approach can make these therapies more effective than traditional chemotherapy and may also lead to less serious side effects.
BRAFTOVI is a BRAF inhibitor, which means it targets certain proteins within cells that have the BRAF mutation. This protein is responsible for cell growth. MEKTOVI is a MEK inhibitor and works by blocking proteins created by this particular gene mutation. The MEK gene works together with the BRAF gene, which is why combination therapies can be more effective than using either type of drug alone.
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When used in combination, BRAFTOVI and MEKTOVI have been the first targeted therapy to demonstrate over 30 months median overall survival in a Phase 3 trial. This two-part, international, randomized Phase 3 trial evaluated the efficacy and safety of BRAFTOVI in combination with MEKTOVI compared to vemurafenib and encorafenib monotherapy in 921 patients with locally advanced, unresectable or metastatic melanoma with the BRAFV600 mutation.
“Unfortunately, melanoma rates have been rising steadily over the last 30 years and this aggressive cancer has taken far too many lives,” said Leslie Yendro, Director of Business Development for Avella. “With the FDA-approval of this important new combination therapy, we can offer patients a treatment option that has demonstrated a meaningful impact on survival rates.”