PIK3CA

FDA approved inavolisib (PI3K inhibitor) with palbociclib and fulvestrant for HR-positive, HER2-negative, PIK3CA-mutated breast cancer. Efficacy shown in trial NCT04191499 with median progression-free survival of 15.0 months vs 7.3 months with placebo. Common adverse reactions include decreased neutrophils, hemoglobin, and platelets, and increased fasting glucose. Inavolisib dose is 9 mg orally daily.

FDA approves inavolisib for endocrine-resistant, PIK3CA-mutated, HR-positive, HER2-negative breast cancer, based on Phase 3 INAVO120 study showing improved progression-free survival and objective response rate.

Foundation Medicine received FDA approval for FoundationOne®Liquid CDx as a companion diagnostic for Itovebi™ (inavolisib) in combination with palbociclib and fulvestrant, for treating endocrine-resistant, PIK3CA-mutated, HR-positive, HER2-negative breast cancer. This marks the seventh companion diagnostic indication for breast cancer, the most for any comprehensive genomic profiling company.

NMPA approves LungCure CDx, a NGS-based companion diagnostic, to guide sunvozertinib use in EGFR exon 20 insertion mutation–positive NSCLC. This marks the first NMPA approval of a co-developed NGS-based companion diagnostic in China. LungCure CDx detects EGFR, MET, ERBB2, KRAS, BRAF, PIK3CA, ALK, ROS1, and RET mutations in NSCLC, aiding targeted therapy selection. Sunvozertinib received NMPA approval for advanced NSCLC with EGFR exon 20 insertion mutations, supported by phase 2 WO-KONH6 trial results. The drug also holds FDA breakthrough therapy designations for relapsed/refractory and frontline NSCLC with EGFR exon 20 insertion mutations.

Turnstone Biologics to lay off 60% of workforce, focus on cancer cell therapy. FDA approves Roche's Itovebi for breast cancer, competing with Novartis' Piqray. Gritstone bio files for bankruptcy, in talks for potential buyer. Sanofi halts Denali Therapeutics' Phase 2 MS trial after study failure. Pfizer's Talzenna-Xtandi combo extends prostate cancer survival. Paul Parker joins Flagship Pioneering as managing partner. Zealand Pharma's hypoglycemia drug dasiglucagon rejected by FDA again.

Roche's PI3K inhibitor Itovebi approved by FDA for use in triple therapy for locally advanced or metastatic HR-positive, HER2-negative breast cancer with PIK3CA mutation. Phase 3 INAVO120 study showed progression-free survival more than doubled to 15 months with Itovebi compared to 7.3 months for control group. Roche predicts Itovebi sales could reach CHF 2 billion annually.

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

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

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

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.