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FDA UPDATE: PIQRAY

FDA Approves First and Only Treatment for Common Mutation in Advanced Breast Cancer

The FDA approved a new drug that is a potential game changer for advanced breast cancer patients. Piqray (alpelisib) gained approval on May 24 for treatment of postmenopausal women and men with one of the most commonly mutated genes in advanced or metastatic breast cancer.

Piqray is the first application for a novel drug to be approved under the FDA’s Real-Time Oncology Review (RTOR) pilot program, which allows for faster evaluation of breakthrough cancer drugs.

Drug manufacturer Novartis launched Piqray with a list price of $15,500 for a 28-day supply. Analysts predict blockbuster status with $1.5 to $2 billion in peak annual sales.

Piqray is the first FDA-approved drug that targets PIK3CA-mutated gene, one of the most commonly mutated genes in breast cancer. It works by inhibiting the PI3K pathway, which has an essential function in allowing cells — including cancer cells — to grow, and may help overcome endocrine resistance in HR+ advanced breast cancer.

Approximately 40% of patients with metastatic breast cancer have tumors that harbor PIK3CA mutations. These mutations play an active role in driving tumor growth and making cancer resistant to various therapies. Patients with PIK3CA mutations are more likely to experience higher tumor growth, be more resistant to endocrine treatment, and have poor overall prognosis.

Piqray offers another non-chemo option and — most importantly — shows significant improvement in progression-free survival.

Efficacy & Safety

The new drug — taken as an oral tablet — gained FDA approval after the promising results of the SOLAR-1 clinical trial, in which 572 participants received the estrogen-blocking drug fulvestrant in combination with either Piqray or a placebo. After monitoring patients for three years, researchers found patients who took the Piqray combination had increased progression-free survival to 11 months versus 5.7 months with fulvestrant alone.

Common side effects include: high blood sugar levels; increase in creatinine, diarrhea, and rash; decrease in blood lymphocyte count; elevated liver enzymes; nausea; fatigue; low red blood cell count; decreased appetite; vomiting; low calcium levels; prolonged blood clotting; and hair loss.

Patients should undergo monitoring of blood glucose and A1C prior to initiation of Piqray and throughout treatment, according to prescribing information available here.

Managing High-Impact Drugs

Upon reviewing effective cost management strategies, MedImpact will make final recommendations regarding formulary placement and utilization management.

To learn more about how MedImpact can help you manage high-impact, high-cost drugs, reduce costs and improve care, go to pbm.medimpact.com.

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