Novartis Korea said Friday that the Ministry of Food and Drug Safety has approved Piqray (ingredient: alpelisib) for treating menopausal patients with advanced breast cancer through combined use with fulvestrant.
The drug can be prescribed to menopausal women with breast cancer whose tumors have PIK3A mutation and are hormone receptor-positive (HR+) and human epidermal growth factor receptor 2 (HER2) negative, according to Novartis Korea.
The ministry authorized the use of Piqray based on phase 3 clinical study results where the company confirmed significant improvement in progressive-free survival (PFS) time. In phase 3 SOLAR-1 study, Piqray prolonged the median PFS of advanced breast cancer patients to 11 months combined with fulvestrant, nearly doubling the 5.7 months recorded in the group treated only with fulvestrant.
The combo therapy also reduced the size of tumors by at least 30 percent in 35.7 percent of breast cancer patients. In contrast, fulvestrant monotherapy helped shrink cancer by about 16.2 percent in the control group.
The PIK3CA gene mutation is most commonly found in breast cancer patients with ongoing HR+ and HER2- progression. About 40 percent of the patients show the genetic mutation in tumors, and they suffer from a poor prognosis.
The overexpression of the PI3K signaling pathway induces resistance against endocrine therapy, a standard breast cancer treatment, and promotes tumor growth.
Piqray is the only PI3K inhibitor for progressive and metastatic breast cancer patients with PIK3CA gene mutations in Korea, according to the company.
“We expect Piqray will become a new therapy for advanced breast cancer patients with PIK3CA gene mutation and HR+ and HER2- progression, said Shin Su-hee, Novartis Korea’s general manager for the oncology business. “As PIK3CA gene mutation is frequently found in HR+ and HER- progressive breast cancer, patients will receive Piqray at the right time if they get a test for genetic mutation.”
She added that the company would continue to provide therapies for progressive breast cancer patients to extend their survival period and improve life quality.