FDA Assigns Review Date for Inavolisib in Metastatic Breast Cancer


The FDA has set a Prescription Drug User Fee Act date of Nov. 27, 2024, to treat patients with PIK3CA-mutated HR-positive, HER2 negative metastatic breast cancer.

The FDA has assigned priority review to Genentech’s new drug application for inavolisib. If approved, inavolisib will be indicated for use in combination with Pfizer’s Ibrance (palbociclib) and fulvestrant. The inavolisib-based regimen was evaluated in adult patients with PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, following recurrence on or within 12 months of completing adjuvant endocrine treatment.

FDA has set a Prescription Drug User Fee Act date of Nov. 27, 2024.

PIK3 is an important pathway involved in cell growth and is activated in many cancers. The PIK3CA mutation is found in about 40% of HR-positive metastatic breast cancers. But available inhibitors of PIK3 can have serious side effects, such as rash, infections, hypertension, hyperglycemia, liver disease and pneumonitis.

Inavolisib is an oral targeted treatment that is designed to minimize the toxicity of other PI3K inhibitors.

The application is based on results of INAV120, a phase 3 trial that showed the inavolisib-based regimen more than doubled progression-free survival and reduced the risk of disease worsening or death by 57% compared with palbociclib and fulvestrant alone in the first-line setting. Overall survival data were immature at the time of primary analysis, but a clear positive trend was observed, according to Genentech officials.

The study included 325 patients. The inavolisib combination was well tolerated. The most common grade 3-4 adverse effects with the inavolisib combination compared with palbociclib and fulvestrant alone were neutropenia, thrombocytopenia, anemia, stomatitis and hyperglycemia. The discontinuation rate in the inavolisib treatment group was 6.8% compared with 0.6% for palbociclib and fulvestrant alone.

Additional analyses of INAVO120 will be presented in an oral abstract session at the 2024 American Society of Clinical Oncology Annual Meeting, which is taking place May 31 - June 4.

Genentech is studying inavolisib in three company-sponsored phase 3 clinical studies (INAVO120, INAVO121, INAVO122) in PIK3CA-mutated locally advanced or metastatic breast cancer in various combinations.

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