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 (alpelisib) is a targeted therapy approved by the FDA and EMA for advanced breast cancer patients whose tumors have a specific mutation in the PIK3CA gene. It works by blocking the signals that tell the cancer cells to grow. Eligible patients can access this treatment in the Boao Lecheng pilot zone under special import pathways.

Regulatory Approvals

• FDA — approved (2019) — label
• EMA — approved (2020) — source

Pivotal Clinical Evidence

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

Sources

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