…………………………catching up on FDA approvals
The FDA recently approved an ORAL therapy, Itovebi (inavolisib) from Genentech, Inc. Itovebi is indicated in combination with palbociclib and fulvestrant for the treatment locally advanced or metastatic breast cancer in adults with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, as detected by an FDA-approved test, following recurrence on or after completing adjuvant endocrine therapy.
Itovebi is a type of targeted therapy medicine called a PI3K inhibitor. Previously, Piqray (alpelisib) was the only PI3K inhibitor approved to treat breast cancer with a PIK3CA mutation. Approximately 70% of all breast cancers are hormone-receptor positive, HER2-negative. PIK3CA is the most commonly mutated gene in hormone-receptor positive, HER2-negative breast cancer, with approximately 40% of patients harboring this mutation.
Genentech said that Itovebi will launch at a price of $22,867 for a 28-day cycle.
Distribution details were not announced. Although it comes with a relatively high cost, Good Rx shows current availability at a large number of retail pharmacies including CVS, Walgreens, Walmart, etc.
CLICK HERE to access prescribing information
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FDA approves inavolisib with palbociclib and fulvestrant for endocrine-resistant, PIK3CA-mutated, HR-positive, HER2-negative, advanced breast cancer
