In response to the FDA approval of inavolisib in combination with palbociclib and fulvestrant for the treatment of PIK3CA-mutated, HR-positive, HER2-negative metastatic breast cancer with disease progression on adjuvant endocrine therapy or with early disease relapse within 12 months of adjuvant endocrine therapy completion, the panel requested the addition of the following language under Useful in Certain Circumstances, First-line Therapy: 

For HER2-negative tumors with PIK3CA activating mutations, and disease progression on adjuvant endocrine therapy or relapse within 12 months of adjuvant endocrine therapy completion see targeted therapy options, see BINV-Q (6)

Please consider the addition of inavolisib in combination with palbociclib and fulvestrant as a first-line treatment option in adults with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, into the NCCN Breast Cancer Guidelines.

Specifically, under “Preferred Regimens”, “First-Line Therapy”, add a new bullet, “Fulvestrant + palbociclib + inavolisib (Category 1)”.

In response to the FDA approval of inavolisib in combination with palbociclib and fulvestrant for the treatment of PIK3CA-mutated, HR-positive, HER2-negative metastatic breast cancer with disease progression on adjuvant endocrine therapy or with early disease relapse within 12 months of adjuvant endocrine therapy completion, the panel requested the addition of inavolisib in combination with palbociclib and fulvestrant for this indication.

Please consider the inclusion of inavolisib in combination with palbociclib and fulvestrant as a first-line treatment option in adults with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, into the NCCN Breast Cancer Guidelines.

Specifically, in the table “Targeted Therapies and Associated Biomarker Testing for Recurrent Unresectable (Local or Regional) or Stage IV (M1) Disease”, add a new row for “Inavolisib + palbociclib + fulvestrant”, with “PIK3CA activating mutation” as detected by “NGS, PCR”, with a “Category 1” listing for “first-line therapy.”

Please consider the inclusion of inavolisib in combination with palbociclib and fulvestrant as a first-line treatment option in adults with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, into the NCCN Breast Cancer Guidelines.  

Specifically, add “inavolisib + palbociclib + fulvestrant” dosing information based on the approved label.

- Inavolisib 9 mg PO once daily on days 1-28 of each 28-day cycle

- Palbociclib 125 mg PO once daily on days 1-21 of each 28-day cycle

- Fulvestrant 500 mg IM on day 1 and day 15 of the first cycle and then on day 1 of every 28-day cycle