Piqray alpelisib

Drug Class

Phosphatidylinositol 3-kinase (PI3K) inhibitor

Mechanism

Inhibits PI3Kα selectively, thereby blocking the PI3K/Akt signaling pathway and suppressing tumor cell growth and proliferation.

Approved Indication

In combination with fulvestrant for hormone receptor (HR)-positive, HER2-negative, PIK3CA-mutated advanced or metastatic breast cancer following progression on or after an endocrine-based regimen.

What This Means For Patients

Piqray is not distributed through mainland China's retail pharmacy network. Uwell Cloud can help arrange a purchase channel for this medicine, sourced and dispatched from Hong Kong; clinical administration support in China can be coordinated on request. Availability and eligibility for any specific patient are determined by clinical review.

Regulatory Approvals

• FDA — Approved (2019) — Sources
• EMA — Approved (2020) — Sources

Pivotal Clinical Evidence

• SOLAR-1 — André et al., N Engl J Med 2019 (NCT02437318) — Sources

Sources

• https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212526s000lbl.pdf
• https://www.ema.europa.eu/en/medicines/human/EPAR/piqray