FDA Approves Itovebi for Locally Advanced, Metastatic Breast Cancer

WEDNESDAY, Oct. 16, 2024 (HealthDay News) -- The U.S. Food and Drug Administration approved Itovebi (inavolisib), in combination with palbociclib (Ibrance) and fulvestrant, for the treatment of adults with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer.

The approval is for the PIK3CA mutation, one of the most commonly mutated genes in HR-positive disease, detected by an FDA-approved test and following recurrence on or after completing adjuvant endocrine therapy.

The approval is based on results of the pivotal phase 3 INAVO120 study. Results from 325 patients showed that the Itovebi-based regimen lowered the risk for disease worsening or death by 57 percent versus palbociclib and fulvestrant alone (15.0 months versus 7.3 months; hazard ratio [HR], 0.43; P < 0.0001) in the first-line setting. At the time of the primary analysis, overall survival data were immature but showed a positive trend (stratified HR, 0.64; P = 0.0338).

“The PI3K pathway plays a pivotal role in disease progression and has been challenging to target,” Komal Jhaveri, M.D., one of the principal investigators of the INAVO120 study, said in a statement. “The Itovebi-based regimen more than doubled progression-free survival and maintained a manageable safety and tolerability profile, adding a new standard in how PIK3CA-mutated breast cancers are treated."   

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