Novartis breast cancer med nabs FDA approval

May 28, 2019

The U.S. FDA has approved Novartis' Piqray treatment in combination with a hormone therapy for postmenopausal women, as well as for men, with a form of advanced breast cancer.

According to the FDA, the drug, alpelisib, is part of a class of drugs known as PI3K inhibitors and is the first of its kind to be approved. It is the first PI3K inhibitor to demonstrate a "clinically meaningful" benefit in treating patients with this type of breast cancer.

Novartis says that PIK3CA is the most commonly mutated gene in HR+/HER2- breast cancer with approximately 40% of patients living with HR+/HER2- breast cancer having this mutation. Piqray targets the effect of PIK3CA mutations and may help overcome endocrine resistance in HR+ advanced breast cancer.

FDA approval is based on results of the Phase III trial, SOLAR-1, that showed Piqray plus fulvestrant nearly doubled median progression-free survival (PFS) compared to fulvestrant alone in HR+/HER2- advanced breast cancer patients with a PIK3CA mutation. Piqray provided consistent PFS results across pre-specified subgroups, including among patients previously treated with a CDK4/6 inhibitor[2],[3].

Overall response rate, was more than doubled when Piqray was added to fulvestrant in patients with a PIK3CA mutation, (ORR= 35.7% vs 16.2% for fulvestrant alone, p=0.0002). Piqray and its associated companion diagnostic test from QIAGEN N.V. was the first new molecular entity and companion diagnostic for multiple sample types approved under the FDA Oncology Center of Excellence Real-Time Oncology Review pilot program.

Patients with HR+/HER2- advanced breast cancer can be selected for treatment with Piqray based on the presence of PIK3CA mutations.

Read the full Novartis release