The FDA approved Array BioPharma’s (ARRY) products Braftovi™ capsules in combination with Mektovi® tablets for unresectable or metastatic skin cancer melanoma with a BRAF or BRAFV mutation, as detected by an FDA-approved test. BRAFTOVI is not indicated for the treatment of patients with wild-type BRAF melanoma.
The products, which represent a new standard of care for BRAF-mutant melanoma are now available to order through select specialty pharmacies in the U.S. market. The combination has been shown to delay disease progression, improve overall survival and is generally well-tolerated.”
Valerie Guild, Co-Founder, and President of the AIM at Melanoma Foundation said, “Nearly half of patients diagnosed with metastatic melanoma test positive for the BRAF mutation. Today’s approval is welcome news for the melanoma community as it arms BRAF-mutant late-stage melanoma patients with an important new targeted treatment in their fight against this devastating disease.”
The approval of Braftovi + Mektovi is based on results from the Phase 3 COLUMBUS trial, which demonstrated the combination doubled median progression-free survival (mPFS) compared to vemurafenib, alone (14.9 months versus 7.3 months, respectively [HR (0.54), (95% CI 0.41-0.71), p<0.0001]). Only 5% of patients who received Braftovi + Mektovi discontinued treatment due to adverse reactions.”
The most common adverse reactions (≥25%) in patients receiving Braftovi + Mektovi were fatigue, nausea, diarrhea, vomiting, abdominal pain, and arthralgia.
Array BioPharma is committed to providing access and reimbursement support to all patients. Array offers a $0 copay for eligible, commercially-insured patients. For more information about the combination Braftovi plus Mektovi, visit www.braftovimektovi.com.
Avella to Distribute Array’s Newly Approved Combination
Array selected Avella to distribute its newly approved combination Braftovi and Mektovi. Avella Specialty Pharmacy, which is headquartered in Phoenix, Arizona, is a National Accredited Specialty Pharmacy, providing individualized care and support to patients since 1996. Its clinical pharmacists and staff members are experts in managing complex disease states and providing compassionate care. The company offers a nationwide distribution service to complement its retail locations.
In 2016, Avella was named Specialty Pharmacy of the Year by NASP, a nationally recognized pharmacy trade committee. Inc. Magazine’s 2017 list of the 5,000 fastest-growing private companies in the country included Avella for the eleventh consecutive year and also recognized Avella as the fastest-growing woman-led company in 2015. In addition, the Arizona Corporate Excellence Awards named Avella Specialty Pharmacy as the second fastest-growing private company based in the state in 2016.
For more information, please visit www.avella.com.
This good news is what we expected from Array based on observations made during our follow up on this firm’s programs and activities for many years. The approval of the combination is indeed, important as the melanoma with the BRAF mutations is the most serious types of melanoma. It is associated with low survival rates.
It is important to note that around half of the 200,000 new yearly diagnosed melanoma cases worldwide have BRAF mutations.
This is great news for melanoma patients with the BRAF mutations, great news for Array Biopharma and delighting news for its shareholders. We congratulate our readers who were not discouraged by the negative articles and market games and volatility to abandon the stock.