Drugs / Inavolisib
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | ITOVEBI | — | 2026-04-15 | fda.gov ↗ |
| Approved | EU (EMA) | Itovebi | — | 2025-07-18 | europa.eu ↗ |
| Approved | US (FDA) | ITOVEBI | — | 2024-10-10 | fda.gov ↗ |
| Filed | US (FDA) | — | PIK3CA-mutated HR-positive, HER2-negative advanced or metastatic breast cancer | 2024-05-28 | “announced today that the U.S. Food and Drug Administration (FDA) has accepted the company’s New Drug Application and granted Priority Review to inavolisib” gene.com ↗ |
Trials 32
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 15 trials | ||||||
| Phase 1 | NCT07144111 | Aug 2025 → Nov 2026 expected | — | Genentech, Inc. | Recruiting | No outcome recorded |
| Phase 1 | NCT06496568 | Dec 2023 → Jul 2027 expected | — | Hoffmann-La Roche | Active not recruiting | No outcome recorded |
| Phase 1 | NCT04929223 | Oct 2021 → Aug 2030 expected | colorectal cancer | Hoffmann-La Roche | Recruiting | No outcome recorded |
| Phase 1 | NCT04449874 | Jul 2020 → Dec 2027 expected | colorectal cancer, non-small cell lung carcinoma | Genentech, Inc. | Active not recruiting | No outcome recorded |
| Phase 1 | NCT03006172 | Dec 2016 → Dec 2026 expected | breast cancer | Genentech, Inc. | Active not recruiting | No outcome recorded |
| Phase 1/23 trials | ||||||
| Phase 1/2 | NCT04486352 | Oct 2021 → Oct 2026 expected | endometrial cancer | Alliance Foundation Trials, LLC. | Recruiting | No outcome recorded |
| Phase 1/2 | NCT04802759 | Jun 2021 → May 2029 expected | estrogen-receptor positive breast cancer | Hoffmann-La Roche | Recruiting | No outcome recorded |
| Phase 1/2 | NCT03424005 | Mar 2018 → Sep 2030 expected | breast cancer | Hoffmann-La Roche | Recruiting | No outcome recorded |
| Phase 219 trials | ||||||
| Phase 2 | NCT07748208 | Oct 2026 → Jun 2029 expected | breast cancer, type 2 diabetes mellitus | Hoffmann-La Roche | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07694973 | Aug 2026 → Jun 2028 expected | pancreatic ductal adenocarcinoma | Fudan University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07618390 | Jun 2026 → Dec 2028 expected | breast cancer | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07522697 | May 2026 → May 2030 expected | endometrial carcinoma | National Cancer Institute, Naples | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07405801 | Apr 2026 → Dec 2028 expected | breast cancer | Hoffmann-La Roche | Recruiting | No outcome recorded |
| Phase 2 | NCT07441512 | Mar 2026 → Mar 2028 expected | triple-negative breast carcinoma | Hu Hai | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07287150 | Mar 2026 → Mar 2028 expected | prostate carcinoma | Hoffmann-La Roche | Recruiting | No outcome recorded |
| Phase 2 | NCT07368998 | Feb 2026 → Oct 2028 expected | breast cancer | Hoffmann-La Roche | Recruiting | No outcome recorded |
| Phase 2 | NCT07323576 | Feb 2026 → Mar 2029 | colorectal cancer | Hoffmann-La Roche | Withdrawn | No outcome recorded |
| Phase 2 | NCT07245797 | Dec 2025 → Dec 2026 expected | breast cancer | Zhimin Shao | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07054190 | Sep 2025 → Jul 2027 expected | breast cancer | Hoffmann-La Roche | Recruiting | No outcome recorded |
| Phase 2 | NCT05708235 | Apr 2024 → Jun 2028 expected | breast cancer | MedSIR | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05332561 | Jun 2023 → Mar 2030 expected | female breast carcinoma | German Cancer Research Center | Recruiting | No outcome recorded |
| Phase 2 | NCT05306041 | Jan 2023 → Jan 2027 expected | HER2 positive breast carcinoma | GBG Forschungs GmbH | Recruiting | No outcome recorded |
| Phase 2 | NCT04551521 | Oct 2021 → Dec 2024 | cancer | German Cancer Research Center | Completed | No outcome recorded |
| Phase 2 | NCT04931342 | Oct 2021 → Feb 2028 expected | ovarian cancer | Hoffmann-La Roche | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04849364 | Aug 2021 → Oct 2024 | triple-negative breast carcinoma | Bryan Schneider, MD | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT04589845 | Jan 2021 → Sep 2032 expected | cancer | Hoffmann-La Roche | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04632992 | Jan 2021 → Dec 2023 | cancer of unknown primary site | Genentech, Inc. | Completed | No outcome recorded |
| Phase 2/31 trial · 1 met primary | ||||||
| Phase 2/3 | NCT04191499 | Jan 2020 → Sep 2023 overdue | breast cancer | Hoffmann-La Roche | Active not recruiting | Met primary |
| Phase 34 trials | ||||||
| Phase 3 | NCT06790693 | Apr 2025 → Jan 2032 expected | breast cancer | Hoffmann-La Roche | Recruiting | No outcome recorded |
| Phase 3 | NCT05894239 | Sep 2023 → Dec 2026 expected | breast cancer | Hoffmann-La Roche | Recruiting | No outcome recorded |
| Phase 3 | NCT05646862 | Jun 2023 → Nov 2026 expected | breast cancer | Hoffmann-La Roche | Recruiting | No outcome recorded |
| Phase 3 | NCT05862285 | Jun 2023 → Mar 2033 expected | cancer | Hoffmann-La Roche | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 18
| Date | Issuer | Release |
|---|---|---|
| 2025-07-23 | Hoffmann-La Roche | Regulatory European Commission approves Roche’s Itovebi for people with ER-positive, HER2-negative, advanced breast cancer with a PIK3CA mutation roche.com ↗ |
| 2025-05-31 | Hoffmann-La Roche | Results New data show Roche’s Itovebi significantly extended survival in a certain type of HR-positive advanced breast cancer roche.com ↗
These data showed ItovebiTM (inavolisib), in combination with palbociclib (Ibrance®) and fulvestrant, reduced the risk of death by more than 30% compared with palbociclib and fulvestrant alone. |
| 2025-05-31 | Genentech, Inc. | Results New Data Show Genentech’s Itovebi Significantly Extended Survival in a Certain Type of HR-Positive Advanced Breast Cancer gene.com ↗
These data showed ItovebiTM (inavolisib), in combination with palbociclib (Ibrance®) and fulvestrant, reduced the risk of death by more than 30% compared with palbociclib and fulvestrant alone. |
| 2025-05-23 | Hoffmann-La Roche | Regulatory CHMP recommends EU approval of Roche’s Itovebi for PIK3CA-mutated, ER-positive, HER2-negative, advanced breast cancer roche.com ↗
Positive recommendation based on phase III INAVO120 data showing ItovebiTM (inavolisib) in combination with palbociclib and fulvestrant more than doubled progression-free survival in the first-line setting1 |
| 2025-01-28 | Hoffmann-La Roche | Results Roche’s Itovebi demonstrated statistically significant and clinically meaningful overall survival benefit in a certain type of HR-positive advanced breast cancer roche.com ↗
The study met its key secondary endpoint, showing a statistically significant and clinically meaningful OS benefit with the Itovebi-based regimen compared with palbociclib and fulvestrant alone. |
| 2025-01-27 | Genentech, Inc. | Results Genentech’s Itovebi Demonstrated Statistically Significant and Clinically Meaningful Overall Survival Benefit in a Certain Type of HR-Positive Advanced Breast Cancer gene.com ↗
The study met its key secondary endpoint, showing a statistically significant and clinically meaningful OS benefit with the Itovebi-based regimen compared with palbociclib and fulvestrant alone. |
| 2024-10-31 | Hoffmann-La Roche | Results New England Journal of Medicine publishes landmark phase III results for Roche’s Itovebi, showing more than doubling of progression-free survival in certain type of HR-positive advanced breast cancer roche.com ↗
ItovebiTM (inavolisib)-based regimen demonstrated a statistically significant and clinically meaningful benefit, reducing the risk of disease worsening or death by 57% compared with palbociclib and fulvestrant alone in the INAVO120 study1 |
| 2024-10-30 | Genentech, Inc. | Results New England Journal of Medicine Publishes Landmark Phase III Results for Genentech’s Itovebi, Showing More Than Doubling of Progression-Free Survival in Certain Type of HR-Positive Advanced Breast Cancer gene.com ↗
ItovebiTM (inavolisib)-based regimen demonstrated a statistically significant and clinically meaningful benefit, reducing the risk of disease worsening or death by 57% compared with palbociclib and fulvestrant alone in the INAVO120 study |
| 2024-10-11 | Hoffmann-La Roche | Regulatory FDA approves Roche’s Itovebi, a targeted treatment for advanced hormone receptor-positive, HER2-negative breast cancer with a PIK3CA mutation roche.com ↗ |
| 2024-10-10 | Genentech, Inc. | Regulatory FDA Approves Genentech’s Itovebi, a Targeted Treatment for Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer With a PIK3CA Mutation gene.com ↗
FDA Approves Genentech’s Itovebi, a Targeted Treatment for Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer With a PIK3CA Mutation |
| 2024-05-29 | Hoffmann-La Roche | Regulatory FDA grants Priority Review to Roche’s inavolisib for advanced hormone receptor-positive, HER2-negative breast cancer with a PIK3CA mutation roche.com ↗
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has accepted the company’s New Drug Application and granted Priority Review to inavolisib, an investigational, oral therapy, in combination with palbociclib (Ibrance®) and fulvestrant. |
| 2024-05-28 | Genentech, Inc. | Regulatory FDA Grants Priority Review to Genentech’s Inavolisib for Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer With a PIK3CA Mutation gene.com ↗
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has accepted the company’s New Drug Application and granted Priority Review to inavolisib, an investigational oral therapy, in combination with palbociclib (Ibrance®) and fulvestrant. |
| 2024-05-21 | Hoffmann-La Roche | Regulatory FDA grants Breakthrough Therapy Designation to Roche’s inavolisib for advanced hormone receptor-positive, HER2-negative breast cancer with a PIK3CA mutation roche.com ↗ |
| 2024-05-20 | Genentech, Inc. | Regulatory FDA Grants Breakthrough Therapy Designation to Genentech’s Inavolisib for Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer With a PIK3CA Mutation gene.com ↗
FDA Grants Breakthrough Therapy Designation to Genentech’s Inavolisib for Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer With a PIK3CA Mutation |
| 2023-12-08 | Hoffmann-La Roche | Results Roche’s inavolisib combination reduces the risk of disease progression by 57% in people with advanced hormone receptor-positive, HER2-negative breast cancer with a PIK3CA mutation roche.com ↗
The inavolisib combination reduced the risk of disease worsening or death (progression-free survival; PFS) by 57% compared to palbociclib and fulvestrant alone (15.0 months vs 7.3 months; hazard ratio [HR]=0.43, 95% CI: 0.32-0.59, p<0.0001). |
| 2023-12-08 | Genentech, Inc. | Results Genentech’s Inavolisib Combination Reduces the Risk of Disease Progression by 57% in People With Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer With a PIK3CA Mutation gene.com ↗
The inavolisib combination reduced the risk of disease worsening or death (progression-free survival; PFS) by 57% compared to palbociclib and fulvestrant alone (15.0 months vs 7.3 months; hazard ratio [HR]=0.43, 95% CI: 0.32-0.59, p<0.0001). |
| 2023-12-05 | Hoffmann-La Roche | Results Roche announces positive Phase III results for inavolisib combination in people with advanced hormone receptor-positive, HER2-negative breast cancer with a PIK3CA mutation roche.com ↗
The study met its primary endpoint of progression-free survival (PFS), demonstrating a statistically significant and clinically meaningful improvement compared to palbociclib and fulvestrant alone. |
| 2023-12-04 | Genentech, Inc. | Results Genentech Announces Positive Phase III Results for Inavolisib Combination in People With Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer With a PIK3CA Mutation gene.com ↗
Phase III (INAVO120) results shows that inavolisib in combination with palbociclib and fulvestrant significantly improved progression-free survival in the first-line setting |
All press releases naming this drug 18 releases
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 34 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Inavolisib | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07748208 ↗ |
| Known as | GDC-0077 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4650215 ↗ |
| Known as | Itovebi | ChEMBL registry synonym — accepted as the source's own label CHEMBL4650215 ↗ |
| Known as | RG-6114 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4650215 ↗ |
| Known as | RO-7113755 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4650215 ↗ |
| Action | Inhibit | “PI3-kinase p110-alpha subunit inhibitor” CHEMBL4650215 ↗1“small-molecule inhibitor of p110α” PMID 39236276 ↗ Sep 2024 |
| Modality | Small molecule | “a potent and selective small-molecule inhibitor of p110α” PMID 39236276 ↗ Sep 2024 |
| Route | Oral | “inavolisib administered orally” NCT03006172 ↗ |
| Target | PIK3CA | “PI3-kinase p110-alpha subunit inhibitor” CHEMBL4650215 ↗ |