Inavolisib
- Generic Name
- Inavolisib
- Brand Names
- -
- Drug Type
- Small Molecule
- Chemical Formula
- C18H19F2N5O4
- CAS Number
- 2060571-02-8
- Unique Ingredient Identifier
- L4C1UY2NYH
- Background
Inavolisib (GDC-0077) is under investigation in clinical trial NCT03006172 (To Evaluate the Safety, Tolerability, and Pharmacokinetics of GDC-0077 Single Agent in Participants With Solid Tumors and in Combination With Endocrine and Targeted Therapies in Participants With Breast Cancer).
- Associated Conditions
- -
- Associated Therapies
- -
Roche gets FDA green light for breast cancer drug Itovebi
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 Roche's Itovebi, a targeted treatment for advanced hormone receptor-positive
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.
Related Clinical Trials:
FDA approves Roche's Itovebi, a targeted treatment for
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.
Related Clinical Trials:
FDA Approves Inavolisib Plus Standard Therapy in PIK3CA-Mutant Breast Cancer
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 the Combination Treatment of Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer With a PIK3CA Mutation
FDA approves Itovebi (inavolisib) for HR-positive, HER2-negative breast cancer with PIK3CA mutation, in combination with palbociclib and fulvestrant.
Related Clinical Trials:
FDA Approves Itovebi (inavolisib) for the Treatment of Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer With a PIK3CA Mutation
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.
Related Clinical Trials:
PI3K Inhibitor Wins FDA Approval for Advanced Breast Cancer
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 in PIK3CA+ Advanced Breast Cancer
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.
Press Releases | Thursday, Oct 10, 2024
FDA approves Genentech's Itovebi for HR-positive, HER2-negative breast cancer with PIK3CA mutation, based on INAVO120 study showing doubled progression-free survival.
Related Clinical Trials:
FDA approves Itovebi regimen for advanced breast cancer
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.
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