- Qiagen said it has launched the first FDA-approved companion diagnostic for identifying breast cancer patients who may benefit from treatment with Novartis' Piqray (alpelisib).
- Novartis last week announced FDA approval of the kinase inhibitor designed specifically for hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer patients with a PIK3CA mutation.
- Qiagen said it has a worldwide co-exclusive license from Johns Hopkins University for PCR-based companion diagnostics based on mutations in the PIK3CA gene.
PIK3CA is the most commonly mutated gene in HR+/HER2- breast cancer. About 40% of HR+ advanced breast cancer patients have the mutation, which is associated with tumor growth, according to Novartis. The Piqray treatment is intended to help those patients battle resistance to endocrine treatment.
In its pivotal trial, Piqray in combination with fulvestrant, an anti-estrogen used to treat hormone-receptor positive metastatic breast cancer, nearly doubled median progression-free survival, compared to fulvestrant alone, in HR+/HER2- advanced breast cancer patients with a PIK3CA mutation, Novartis said. Progression-free survival increased to 11.0 months from 5.7 months.
The Novartis drug is indicated in combination with fulvestrant for the treatment of postmenopausal women and men with HR+/HER2- PIK3CA-mutated, advanced or metastatic breast cancer as detected by an FDA-approved test following progression on an endocrine-based regimen.
Qiagen said its companion assay detects 11 PIK3CA mutations. The co-approval of the Therascreen PIK3CA Kit with PIQRAY marks the seventh FDA approval of a therapy with a Qiagen companion diagnostic assay, the Netherlands-based test maker said.
The kit is the first companion diagnostic assay to receive FDA premarket approval for use in any cancer indication to detect activating mutations in the PIK3CA gene and the first FDA-approved assay for breast cancer to use plasma specimens as a liquid biopsy, Qiagen said. The real-time qualitative kit is processed on QIAGEN's Rotor-Gene Q MDx instrument used for automated amplification and detection.
Qiagen said the Therascreen PIK3CA Kit is available immediately at certain U.S. laboratories.