From the FDA Drug Label
1 INDICATIONS AND USAGE
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From the Research
Inavolisib is currently indicated for the treatment of hormone receptor-positive (HR+), HER2-negative, PIK3CA-mutated advanced or metastatic breast cancer in adult patients, in combination with palbociclib and fulvestrant, after disease progression following at least one line of endocrine therapy. The FDA approved this indication in October 2024, as reported in the study by 1. The typical dosing is not explicitly stated in the most recent and highest quality study, but based on the available evidence, patients should be selected for treatment based on the presence of a PIK3CA mutation in tumor tissue or plasma specimens, using an FDA-approved test.
Key Points
- Inavolisib works by selectively inhibiting the PI3K-alpha isoform, which is frequently mutated in breast cancer, leading to hyperactivation of the PI3K/AKT/mTOR pathway that drives cancer cell growth and proliferation.
- Common side effects include hyperglycemia, diarrhea, rash, stomatitis, and pneumonitis, so regular monitoring of blood glucose levels and assessment for these adverse effects is necessary during treatment, as noted in the study by 2.
- The study by 2 also reported that inavolisib plus palbociclib-fulvestrant led to significantly longer progression-free survival than placebo plus palbociclib-fulvestrant, with a greater incidence of toxic effects.
Treatment Considerations
- Patients with PIK3CA-mutated, hormone receptor-positive, HER2-negative locally advanced or metastatic breast cancer may benefit from inavolisib treatment, as shown in the study by 2.
- The study by 3 reported a manageable safety profile and promising preliminary antitumor activity for inavolisib plus palbociclib and endocrine therapy.
- Regular monitoring of patients for adverse effects and adjustment of treatment as needed is crucial to minimize toxicity and maximize efficacy.