FDA approves Itovebi for locally advanced, metastatic breast cancer


The US Food and Drug Administration has 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% 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, MD, 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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Citation: FDA approves Itovebi for locally advanced, metastatic breast cancer (2024, October 16) retrieved 17 October 2024 from

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