Genentech’s Itovebi Approved By FDA For Advanced Breast Cancer Treatment

Genentech, part of the Roche Group, announced FDA approval of Itovebi™ (inavolisib) for adults with endocrine-resistant, PIK3CA-mutated, hormone receptor-positive, HER2-negative, locally advanced or metastatic breast cancer. This treatment combines palbociclib (Ibrance®) and fulvestrant, following recurrence after adjuvant therapy.

“The PI3K pathway plays a pivotal role in disease progression and has been challenging to target. 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,” said Komal Jhaveri, M.D., section head for the endocrine therapy research portfolio and clinical director of the early drug development service at Memorial Sloan Kettering Cancer Center, and one of the principal investigators of the INAVO120 study.

Levi Garraway, M.D., Ph.D., Genentech’s chief medical officer and head of Global Product Development, said.“With the approval of this Itovebi-based regimen, we continue our long-standing track record of cancer therapeutic discovery by offering an important new first-line option for people living with HR-positive breast cancer with a PIK3CA mutation. Despite the high prevalence of PIK3CA mutations in this setting, treatment options have thus far remained limited, which makes today’s approval all the more significant.”

The approval is based on the Phase III INAVO120 study, which showed a 57% reduction in disease progression or death compared to the standard regimen (15.0 months vs. 7.3 months). Although overall survival data are still developing, a positive trend was noted.

“We are thrilled by the approval of the Itovebi-based regimen, which is a huge step forward for advanced breast cancer patients with a PIK3CA mutation. It remains critical that all patients have access to early, comprehensive biomarker testing so they can better understand what treatment options may be most beneficial for them and their tumour type,” said Jean Sachs, CEO of Living Beyond Breast Cancer.

Itovebi received FDA Priority Review and Breakthrough Therapy Designation in May 2024. The drug will be available in the U.S. soon, with ongoing biomarker testing helping to identify suitable patients. Itovebi is also being studied in three additional Phase III trials for PIK3CA-mutated breast cancer, with plans to explore further oncology opportunities.