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FDA Approves Genentech's Itovebi Combo for PIK3CA-Mutated Advanced Breast Cancer Patients

NEW YORK – The US Food and Drug Administration on Thursday approved Genentech's PI3Kα inhibitor Itovebi (inavolisib) with Pfizer's CDK4/6 inhibitor Ibrance (palbociclib) and the anti-estrogen therapy fulvestrant as a combination treatment for patients with advanced, PIK3CA-mutated, hormone receptor-positive, HER2-negative breast cancer. 

The agency approved the regimen based on the results of the Phase III INAVO120 clinical trial, in which patients who received Itovebi plus Ibrance and fulvestrant lived for a median of 15 months without their cancers progressing, whereas patients who received Ibrance and fulvestrant alone lived for a median of 7.3 months without their cancers progressing. 

To be eligible for the treatment, patients' breast cancers must have progressed following endocrine therapy. 

"The PI3K pathway plays a pivotal role in disease progression and has been challenging to target," Komal Jhaveri, the clinical director of early drug development at Memorial Sloan Kettering and one of the principal investigators on 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." 

Genentech, a subsidiary of Roche, said in a statement that early biomarker testing on Foundation Medicine's blood-based next-generation sequencing assay, FoundationOne Liquid CDx, could help identify patients eligible for Itovebi. The FDA on Friday approved the next-generation sequencing test as a companion diagnostic to select patients for the Itovebi regimen. 

Genentech is also seeking regulatory approval for Itovebi-based regimens in regions outside the US, including the EU.