Breast cancer PIK3CA mutation PI3K inhibitor FDA approval with CDK4/6 inhibitor combination treatment
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AstraZeneca Receives FDA Approval for Inavolisib in PIK3CA-Mutated Breast Cancer

AstraZeneca announces FDA approval of inavolisib plus palbociclib plus fulvestrant for PIK3CA-mutated HR+/HER2- advanced breast cancer.

AstraZeneca today announced that the FDA has approved inavolisib plus palbociclib plus fulvestrant for the treatment of adults with endocrine-resistant PIK3CA-mutated hormone receptor-positive, HER2-negative locally advanced or metastatic breast cancer. In the Phase 3 INAVO120 trial, the combination demonstrated a statistically significant improvement in progression-free survival, with a median PFS of 15.0 months versus 7.3 months for placebo plus palbociclib plus fulvestrant. Inavolisib is a selective PI3Kα inhibitor that degrades mutant PI3Kα.

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