ALPELISIB, the first treatment for certain types of advanced breast cancer, was approved this July by the Philippine Food and Drug Administration (FDA).
PIK3CA is the most commonly mutated gene in hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) breast cancer.
“Alpelisib was discovered at the Novartis Institutes for BioMedical Research. It is the first-ever treatment specifically for HR+/HER2- advanced breast cancer with a PIK3CA mutation,” said Joel Chong, country president, Novartis Healthcare Philippines, Inc., in a statement.
“The regulatory approval of alpelisib is a game changer in the way we practice medicine in advanced breast cancer. 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,” added Dr. Arnold John B. Uson, president, Philippine Society of Medical Oncology.
Testing for PIK3CA mutation, which is associated with tumor growth and a resistance to endocrine treatment, can help personalize treatment and improve outcomes for Filipino women in the advanced stages of the disease, according to cancer experts.
“Patients with a PIK3CA mutation need to be identified through genetic testing because they face a worse prognosis,” said Dr. Eva Maria Cutiongco-de la Paz, executive director of University of the Philippines-National Institutes of Health, at a July 21 forum organized by Novartis Healthcare Philippines.
“Through testing for PIK3CA, they’ll be given a better chance of survival,” she added.
Cancer is the third leading cause of death in the country, as per the Philippine Statistics Authority. Breast cancer itself is also the third leading cause among cancer-related deaths after lung and liver cancer.
Dr. Rose Lou Marie C. Agbay, consultant director of The Medical City (TMC) laboratory medicine and pathology department’s molecular diagnostics section, encouraged patients to ask their doctors about PIK3CA, and doctors to consider it for their patients.
“Knowing the PIK3CA mutation status of a tumor is helpful in improving outlook for progressive or persistent breast cancer. There is a targeted treatment option available for breast cancer that is PIK3CA-positive,” she explained.
Researchers and administrators from Novartis, TMC, Hi-Precision Diagnostics, and the Philippine Society of Medical Oncology, jointly conducted the testing program locally.
“This is a step forward in personalized medicine, where patients will be confident when choosing treatments because they know in advance whether this drug will work for them, or not,” said Joel Chong, Novartis Philippines’ president.
Around 40% of patients with HR+/HER2- breast cancer have the PIK3CA gene. Detecting it involves a standard biopsy or liquid biopsy through blood samples.