Inavolisib

The FDA approved inavolisib, palbociclib, and fulvestrant for HR+, HER2–, PIK3CA-mutated breast cancer, supported by the phase 3 INAVO120 study. Inavolisib reduced progression risk by 57% and improved progression-free survival to 15.0 months vs 7.3 months with placebo.

FDA approves Itovebi (inavolisib) for HR-positive, HER2-negative breast cancer with PIK3CA mutation, in combination with palbociclib and fulvestrant.

FDA approves Itovebi (inavolisib) for HR-positive, HER2-negative breast cancer with PIK3CA mutation, in combination with palbociclib and fulvestrant, based on INAVO120 study results showing significant progression-free survival improvement.

FDA approves inavolisib (Itovebi) in combination with palbociclib and fulvestrant for locally advanced, PIK3CA-mutated, HR-positive/HER2-negative breast cancer. INAVO120 trial showed inavolisib more than doubled median progression-free survival (PFS) to 15 months from 7.3 months. Common adverse events include neutrophil, hemoglobin, and platelet decreases, and increases in fasting glucose and creatinine.

FDA approves inavolisib combo with palbociclib and fulvestrant for endocrine-resistant, PIK3CA-mutated, HR-positive, HER2-negative breast cancer, based on INAVO120 trial data showing improved progression-free survival and response rates.

FDA approves Genentech's Itovebi for HR-positive, HER2-negative breast cancer with PIK3CA mutation, based on INAVO120 study showing doubled progression-free survival.

FDA approves inavolisib (Itovebi) with palbociclib and fulvestrant for endocrine-resistant, PIK3CA-mutated, hormone receptor-positive, HER2-negative advanced breast cancer, based on INAVO120 trial results showing improved PFS, ORR, and duration of response.

FDA approves inavolisib triplet therapy for ER+/HER2- breast cancer with PIK3CA mutation, significantly extending progression-free survival in phase 3 trial.

The FDA approved inavolisib in combination with palbociclib and fulvestrant for endocrine-resistant, PIK3CA-mutated, HR-positive, HER2-negative, locally advanced or metastatic breast cancer. The FoundationOne Liquid CDx assay was also approved as a companion diagnostic. The approval was based on the INAVO120 trial, showing median PFS of 15 months vs. 7.3 months with ORR of 58% vs. 25%. Common adverse reactions included decreased neutrophils, decreased hemoglobin, and increased fasting glucose.

The FDA approved inavolisib (Itovebi) plus palbociclib and fulvestrant for endocrine-resistant, PIK3CA-mutant, HR-positive, HER2-negative advanced breast cancer. The approval is based on the INAVO120 trial, showing improved progression-free survival (PFS) and objective response rate (ORR) with inavolisib. Common adverse events included decreased neutrophils, hemoglobin, and platelets, and increased fasting glucose and creatinine.