Fotivda

(Inavolisib)

ApprovedSmall molecule

Inavolisib is used to treat certain types of breast cancer and blood cancers by blocking proteins that help cancer cells grow and survive.[2] Fotivda is currently approved and in use across 12 indications[4].[1]

Fotivda is one of 283 small molecule programs targeting Breast Neoplasm. It is currently in Approved.

Indications

Total Trials

Active Trials

282

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Breast NeoplasmActive, not recruiting

Metastatic Colorectal CancerActive, not recruiting

Breast CancerActive, not recruiting

Colorectal CancerActive, not recruiting

Prostate CancerActive, not recruiting

CholangiocarcinomaActive, not recruiting

Endometrial CancerActive, not recruiting

Metastatic Castration-Resistant Prostate CancerRecruiting

Hepatic ImpairmentRecruiting

Metastatic Breast CancerRecruiting

Breast NeoplasmApproved

Active, not recruiting

Metastatic Colorectal CancerPhase 1

Active, not recruiting

Breast CancerPhase 3

Active, not recruiting

Colorectal CancerPhase 2

Active, not recruiting

Prostate CancerPhase 2

Active, not recruiting

CholangiocarcinomaPhase 3

Active, not recruiting

Endometrial CancerPhase 1/Phase 2

Active, not recruiting

Metastatic Castration-Resistant Prostate CancerPhase 2

Recruiting

Hepatic ImpairmentPhase 1

Recruiting

Metastatic Breast CancerPhase 3

Recruiting

Showing 10 of 12 indications

Competition

Competitive Landscape

2828 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Fotivda

Roche

Approved

11 2

Halaven

Eisai

Preclinical

38 3

Tykerb

GSK

Preclinical

80 4

Avastin

Prolia

14 6

Blenoxane

Bristol-Myers Squibb

Preclinical

1 7

Lexiscan

Astellas

Preclinical

1 8

Adenocard

Astellas

Preclinical

1 9

Voltaren

Novartis

Preclinical

1 10

Sporanox

SSebela Pharmaceuticals Development LLC

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2026

Phase 1Recruiting

Hepatic Impairment

NCT07144111

Q4 2026

Phase 3Active, not recruiting

Cholangiocarcinoma

NCT04551521

Phase 1Active, not recruiting

Breast Cancer

NCT03006172

Q1 2027

Phase 2Recruiting

Breast Cancer

NCT05306041

Q3 2027

Phase 2Recruiting

Breast Cancer

NCT07054190

Clinical

Trials by Indication[1]

Breast Cancer11 trials

A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer

Recruiting· Roche logo

Roche·Phase 1/2·NCT03424005·792 enrolled

Genomics Guided Targeted Post-neoadjuvant Therapy in Patients With Early Breast Cancer (COGNITION-GUIDE)

Recruiting·GGerman Cancer Research Center·Phase 2·NCT05332561·240 enrolled

Neoadjuvant Endocrine Therapy +/- the PI3K Inhibitor Inavolisib in HER2+, HR+, PIK3CA Mutant Early Breast Cancer

Recruiting·GGBG Forschungs GmbH·Phase 2·NCT05306041·170 enrolled

Show 8 more trials

A Study Evaluating the Efficacy and Safety of Inavolisib + Palbociclib + Fulvestrant vs Placebo + Palbociclib + Fulvestrant in Participants With PIK3CA-Mutant, Hormone Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer

Active, not recruiting· Roche logo

Roche·Phase 2/3·NCT04191499·325 enrolled

Circulating Tumor DNA Enriched, Genomically Directed Post-neoadjuvant Trial for Patients With Residual Triple Negative Breast Cancer

Terminated·—·Phase 2·NCT04849364·52 enrolled

To Evaluate the Safety, Tolerability, and Pharmacokinetics of Inavolisib Single Agent in Participants With Solid Tumors and in Combination With Endocrine and Targeted Therapies in Participants With Breast Cancer

Active, not recruiting· Roche logo

Roche·Phase 1·NCT03006172·200 enrolled

A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib Plus Fulvestrant Versus Placebo Plus Ribociclib Plus Fulvestrant in Patients With Endocrine- Resistant Hormone-Receptor-Positive, HER2-Negative Advanced Breast Cancer With Chromosome 8P Loss and Without a PIK3CA Mutation

Recruiting· Roche logo

Roche·Phase 2·NCT07405801·80 enrolled

A Phase II, Randomized, Open-Label Study Evaluating Two Inavolisib Dose Levels in Combination With Fulvestrant in Participants With PIK3CA-Mutated, HR-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer

Recruiting· Roche logo

Roche·Phase 2·NCT07368998·80 enrolled

A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Inavolisib Plus a CDK4/6 Inhibitor and Letrozole Versus Placebo Plus a CDK4/6 Inhibitor and Letrozole in Patients With Endocrine-Sensitive PIK3CA-Mutated, Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer

Recruiting· Roche logo

Roche·Phase 3·NCT06790693·450 enrolled

A Phase III, Multicenter, Randomized, Open-Label Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Versus Alpelisib Plus Fulvestrant in Patients With Hormone Receptor-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Who Progressed During or After CDK4/6 Inhibitor and Endocrine Combination Therapy

Active, not recruiting· Roche logo

Roche·Phase 3·NCT05646862·420 enrolled

A Phase II, Open-Label, Multicenter Study Evaluating the Safety and Efficacy of Neoadjuvant Treatment With Inavolisib Combinations in Patients With Untreated, Early-stage, PIK3CA-Mutated Breast Cancer

Recruiting· Roche logo

Roche·Phase 2·NCT07054190·60 enrolled

HER2-Negative1 trial

A PoC Study to Evaluate Treatments' Efficacy by Monitoring MRD Using ctDNA in HR-positive/HER2-negative EBC Population

Recruiting·MMedSIR·Phase 2·NCT05708235·976 enrolled

Oncology1 trial

Tumor-agnostic Precision Immuno-oncology and Somatic Targeting Rational for You (TAPISTRY) Platform Study

Recruiting· Roche logo

Roche·Phase 2·NCT04589845·920 enrolled

PIK3CA-Mutated Cancers1 trial

A Study Evaluating Single-agent Inavolisib, Inavolisib Plus Atezolizumab, and Inavolisib Plus Pembrolizumab in PIK3CA-Mutated Cancers

Recruiting· Roche logo

Roche·Phase 1·NCT06496568·30 enrolled

Endometrial Cancer1 trial

A Study of Targeted Agents for Patients With Recurrent or Persistent Endometrial Cancer

Recruiting·AAlliance Foundation Trials, LLC.·Phase 1/2·NCT04486352·148 enrolled

13 more indications

Efficacy and Safety1 trial

A Study Evaluating the Efficacy and Safety of Biomarker-Driven Therapies in Patients With Persistent or Recurrent Rare Epithelial Ovarian Tumors

Active, not recruiting· Roche logo

Roche·Phase 2·NCT04931342·176 enrolled

Advanced Solid Tumors1 trial

A Study Evaluating Targeted Therapies in Participants Who Have Advanced Solid Tumors With Genomic Alterations or Protein Expression Patterns Predictive of Response

Completed· Roche logo

Roche·Phase 2·NCT04632992·252 enrolled

Colorectal Cancer1 trial

A Study to Evaluate the Efficacy and Safety of Inavolisib When Administered in Combination With Bevacizumab and FOLFOX or FOLFIRI as First Line Therapy in Participants With Colorectal Cancer

Withdrawn· Roche logo

Roche·Phase 2·NCT07323576

Advanced or Metastatic Solid Tumors1 trial

A Study to Evaluate the Safety, Pharmacokinetics, and Activity of GDC-6036 Alone or in Combination in Participants With Advanced or Metastatic Solid Tumors With a KRAS G12C Mutation

Active, not recruiting· Roche logo

Roche·Phase 1·NCT04449874·498 enrolled

Locally Advanced Breast Cancer1 trial

A Non-interventional Study to Evaluate the Effectiveness and Safety of Inavolisib in Patients With Endocrine-resistant, PIK3CA-mutated, Hormone Receptor-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer (reaINAVO)

Recruiting· Roche logo

Roche··NCT07347600·500 enrolled

Pancreatic Ductal Adenocarcinoma (PDAC)1 trial

A Multicenter, Single Arm Study to Evaluate the Preliminary Efficacy and Safety Profile of Inavolisib in Previously Treated Pancreatic Ductal Adenocarcinoma Patients

Not yet recruiting·FFudan University·Phase 2·NCT07694973·62 enrolled

Hepatic Impairment1 trial

A Phase 1, Open-Label, Single-Dose Study to Evaluate the Effect of Moderate or Severe Hepatic Impairment on the Pharmacokinetics of Inavolisib

Recruiting· Roche logo

Roche·Phase 1·NCT07144111·32 enrolled

Metastatic Castration-Resistant Prostate Cancer1 trial

A Phase II, Randomized, Multicenter, Open-Label Study Evaluating the Efficacy and Safety of the Combination of Inavolisib Plus Enzalutamide Versus Physician's Choice of ARPI or Docetaxel in Patients With Metastatic Castration-Resistant Prostate Cancer

Recruiting· Roche logo

Roche·Phase 2·NCT07287150·100 enrolled

Inoperable, Locally Advanced or Metastatic, ER-positive Breast Cancer1 trial

A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Breast Cancer (MORPHEUS-BREAST CANCER)

Recruiting· Roche logo

Roche·Preclinical·NCT04802759·316 enrolled

Metastatic Breast Cancer1 trial

A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in Combination With Phesgo As Maintenance Therapy After First Line Induction Therapy in Participants With PIK3CA-Mutated HER2-Positive Locally Advanced or Metastatic Breast Cancer

Recruiting· Roche logo

Roche·Phase 3·NCT05894239·230 enrolled

Metastatic Colorectal Cancer1 trial

A Phase I/Ib Global, Multicenter, Open-label Umbrella Study Evaluating the Safety and Efficacy of Targeted Therapies in Subpopulations of Patients With Metastatic Colorectal Cancer (INTRINSIC)

Recruiting· Roche logo

Roche·Phase 1·NCT04929223·542 enrolled

Cholangiocarcinoma1 trial

FIGHT-302: Pemigatinib vs Chemo in FGFR2+ CCA

Active, not recruiting· Incyte logo

Incyte·Phase 3·NCT04551521·432 enrolled

Unspecified1 trial

An Open-Label, Multicenter Extension Study in Patients Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd Sponsored Study

Recruiting· Roche logo

Roche·Phase 3·NCT05862285·100 enrolled

Regulatory

FDA Approval Timeline[5]

Oct 10, 2024

ITOVEBI

NDA NDA219249

Sources

References

[1]
ClinicalTrials.gov — 28 trial records for Inavolisib. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Fotivda drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Inavolisib compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Inavolisib. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA219249). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Fotivda. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Roche company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: PI3-Kinase P110-Alpha Subunit Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Roche

Patent Landscape[6]

Patent Cliff

Sep 27, 2030

Earliest patent expiration — generic entry possible after this date

Patent #Expires

8343955Sep 27, 2030

8242104Sep 27, 2030

9650393Jul 1, 2036

11760753Jul 1, 2036

10851091Jul 1, 2036

2 more patents

11028100Apr 26, 2038

12410189Jun 14, 2038

Fotivda

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q3 2026

Q4 2026

Q1 2027

Q3 2027

Trials by Indication[1]

Breast Cancer11 trials

HER2-Negative1 trial

Oncology1 trial

PIK3CA-Mutated Cancers1 trial

Endometrial Cancer1 trial

Efficacy and Safety1 trial

Advanced Solid Tumors1 trial

Colorectal Cancer1 trial

Advanced or Metastatic Solid Tumors1 trial

Locally Advanced Breast Cancer1 trial

Pancreatic Ductal Adenocarcinoma (PDAC)1 trial

Hepatic Impairment1 trial

Metastatic Castration-Resistant Prostate Cancer1 trial

Inoperable, Locally Advanced or Metastatic, ER-positive Breast Cancer1 trial

Metastatic Breast Cancer1 trial

Metastatic Colorectal Cancer1 trial

Cholangiocarcinoma1 trial

Unspecified1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

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