FDA clears novel breast cancer drug


FDA cleared alpelisib (Piqray), the first PI3K inhibitor to treat breast cancer, to be used in combination with fulvestrant (Faslodex).

headshot  Richard Pazdur


FDA approved alpelisib (Piqray, Novartis) tablets, the first PI3K inhibitor to treat breast cancer, to be used in combination with fulvestrant (Faslodex, AstraZeneca).

The drug combination is approved for use in postmenopausal women and men 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.

FDA also approved the companion diagnostic test, therascreen PIK3CA RGQ PCR Kit (Qiagen Manchester), to detect the PIK3CA mutation in a tissue and/or a liquid biopsy. Patients who are negative by the therascreen test using the liquid biopsy should undergo tumor biopsy for PIK3CA mutation testing.

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Piqray is the first novel drug approved under FDA’s Real-Time Oncology Review pilot program.

“Piqray is the first PI3K inhibitor to demonstrate a clinically meaningful benefit in treating patients with this type of breast cancer. The ability to target treatment to a patient’s specific genetic mutation or biomarker is becoming increasingly common in cancer treatment, and companion diagnostic tests assist oncologists in selecting patients who may benefit from these targeted treatments,” said Richard Pazdur, MD, director of FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, in a FDA statement.

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The approval is “expected to change the way we practice medicine in advanced breast cancer,” said Fabrice André, MD, PhD, professor in the Department of Medical Oncology at Institut Gustave Roussy in Villejuif, France, and global SOLAR-1 principal investigator, in a statement from Novartis. “For the first time, physicians can test for PIK3CA biomarkers and develop a treatment plan based on the genomic profile of a patient's cancer.”

In the SOLAR-1 phase 3 trial of 572 postmenopausal women and men with HR-positive, HER2-negative advanced or metastatic breast cancer, alpelisib plus fulvestrant nearly doubled median progression-free survival and more than doubled overall response rate in patients with a PIK3CA mutation, André said.

Piqray is the first new drug application (NDA) for a new molecular entity approved under the Real-Time Oncology Review (RTOR) pilot program, which permits FDA to begin analyzing key efficacy and safety datasets prior to the official submission of an application, FDA said. FDA granted the application priority review designation.

Read more: Top 3 new drug approvals

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