PIQRAY® (alpelisib) FDA Approved for the Treatment of Patients with a PIK3CA Mutation in HR+/HER2- Advanced Breast Cancer , Available Exclusively at Biologics by McKesson

Cary, N.C., August 7, 2025 – Effective June 15, PIQRAY® (alpelisib) is now exclusively available at Biologics by McKesson, an independent specialty pharmacy specializing in oncology and rare disease areas. PIQRAY® is a kinase inhibitor indicated in combination with fulvestrant for the treatment of adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer as detected by an FDA-approved test following progression on or after an endocrine-based regimen.

Mutations in the PIK3CA gene are the most frequent genetic alterations found in HR-positive/HER2-negative breast cancer, occurring in approximately 40% of cases. These mutations are known to drive tumor growth, contribute to resistance against endocrine therapies, and are associated with a poor overall prognosis.

“For the many people living with HR-positive/HER2-negative breast cancer, a PIK3CA mutation can make an already difficult journey even more challenging. That’s why timely access to the right treatment, paired with compassionate, expert support, is so essential. We are truly grateful to be chosen as the exclusive specialty pharmacy for PIQRAY,” said Ela Lourido, vice president and general manager of Biologics by McKesson. “This recognition is a testament to the dedication of our team and the trust placed in us to provide compassionate, personalized care to patients navigating complex cancer treatments. We are proud to stand alongside patients and providers at every step of their journey.”

Biologics by McKesson is committed to and recognized for its level of customer service as well as its innovative, high-touch, and multidisciplinary approach. Putting patients first in all they do, the Biologics’ pharmacy team includes pharmacists with in-depth knowledge of therapies, experienced nurses, and financial counselors who are familiar with various financial assistance programs and organizations that help patients.

Healthcare providers can visit piqray-hcp.com for more information about PIQRAY®.

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