Inavolisib Combo Gets FDA Priority Review in HR-Positive, HER2-Negative Breast Cancer

Inavolisib plus Ibrance and fulvestrant has been granted a priority review by the FDA for certain patients with breast cancer.

The Food and Drug Administration (FDA) has accepted a new drug application and granted priority review to inavolisib in combination with Ibrance (palbociclib) and fulvestrant for the treatment of adult patients with PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer following recurrence on or within a year of completing adjuvant (postsurgical) endocrine treatment.

The FDA is expected to make a decision on the treatment by Nov. 27, 2024, according to a press release from Roche, the manufacturer of inavolisib.

Priority review designation, according to the FDA’s website, is reserved for “drugs that, if approved, would be significant improvements in the safety or effectiveness of the treatment, diagnosis or prevention of serious conditions when compared to standard applications.”

Roche had previously announced that the FDA had granted breakthrough therapy designation for the inavolisib, Ibrance and fulvestrant combination. Breakthrough therapy designation, the FDA stated on its website, is intended to “expedite the development and review of drugs that are intended to treat a serious condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s).”

The priority review, according to Roche, is based on the findings of the phase 3 INAVO120 trial, which showed that the combination regimen reduced the risk of disease worsening or death by 57% versus treatment with Ibrance and fulvestrant alone, with a median progression-free survival (how long a patient lives without their disease spreading or worsening) of 15 months and 7.3 months, respectively, in the first-line setting.

“The addition of inavolisib to standard-of-care treatment significantly delayed disease progression in the first-line setting and has the potential to extend survival for people with metastatic breast cancers that harbor PIK3CA mutations,” said Dr. Levi Garraway, Roche’s chief medical officer and head of global product development, in the company’s news release.

Further analysis from the INAVO120 trial is expected to be presented during the 2024 American Society of Clinical Oncology Annual Meeting, Roche stated.

While Roche noted in the news release that data regarding overall survival (how long a patient lives following treatment, regardless of disease status) was not yet available, the company did state that a positive trend had been observed favoring those patients who had been treated with the inavolisib combination.

Regarding side effects, Roche stated in late 2023 that the inavolisib combination was well-tolerated by patients and that side effects “were consistent with the known safety profiles of the individual study treatments, with no new safety signals observed.”

Inavolisib is an oral drug that, according to the National Cancer Institute, is designed to inhibit the growth and survival of PI3K-overexpressing tumor cells.

With 325 participants, INAVO120 is estimated to be completed in September 2030, according to its listing on It is one of three current phase 3 trials investigating inavolisib in other combinations for the treatment of PIK3CA-mutated locally advanced or metastatic breast cancer, the company reported.

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