Inavolisib

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The FDA approved inavolisib plus palbociclib and fulvestrant for endocrine-resistant, PIK3CA-mutated, HR+/HER2- breast cancer, based on INAVO120 trial data showing improved median PFS (15.0 months vs. 7.3 months). This marks a significant milestone, offering a new therapeutic approach for patients with high-risk early progression and manageable toxicity.

RMC-9805, a covalent KRAS(G12D)(ON) molecular glue inhibitor, employs a CypA-recruiting tricomplex mechanism and an aziridine covalent handle to target the 'undruggable' KRAS(G12D) mutant. Structural and modeling insights were crucial for engaging the mutant Asp, and RMC-9805 synergizes with PD-1 inhibitors, showing clinical progress.

FDA approves Genentech's Itovebi (inavolisib) for HR+/HER2- breast cancer with PIK3CA mutation, in combo with Ibrance and fulvestrant. FoundationOneLiquid CDx is approved as a companion diagnostic. Itovebi aims to reduce toxicity of other PI3K inhibitors, with a 28-day cycle costing $22,867. Phase 3 INAVO120 data showed Itovebi regimen doubled progression-free survival vs. Ibrance and fulvestrant alone, reducing risk of disease worsening or death by 57%.

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.

Roche’s PI3K inhibitor Itovebi (inavolisib) approved by FDA for advanced breast cancer in combination with Pfizer’s Ibrance and fulvestrant. INAVO120 study showed 57% reduction in disease worsening or death risk. Itovebi to be available in the US soon, with submissions to other global health authorities ongoing.

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 breast cancer, based on INAVO120 study results showing doubled progression-free survival.