Alecensa

(Alectinib)

ApprovedSmall molecule

Alectinib is used to treat a specific type of lung cancer (ALK-positive non-small cell lung cancer) in patients whose cancer has spread or who cannot have surgery.[2] Alecensa is currently approved and in use across 28 indications[4].[1]

Alecensa is one of 645 small molecule programs targeting Lung Cancer. It is currently in Approved.

Indications

Total Trials

Active Trials

644

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Lung CancerActive, not recruiting

Non-Small Cell Lung CancerActive, not recruiting

Lung Signet Ring Cell CarcinomaActive, not recruiting

Central Nervous System CancerApproved

Liver DiseaseApproved

Hepatocellular CarcinomaApproved

Erectile DysfunctionActive, not recruiting

ToxicityActive, not recruiting

Haematological MalignancyRecruiting

Malignant Solid TumorRecruiting

Lung CancerPhase 3

Active, not recruiting

Non-Small Cell Lung CancerPhase 3

Active, not recruiting

Lung Signet Ring Cell CarcinomaPreclinical

Active, not recruiting

Central Nervous System CancerApproved

Approved

Liver DiseaseApproved

Approved

Hepatocellular CarcinomaApproved

Approved

Erectile DysfunctionPreclinical

Active, not recruiting

ToxicityPreclinical

Active, not recruiting

Haematological MalignancyPreclinical

Recruiting

Malignant Solid TumorPhase 2

Recruiting

Showing 10 of 28 indications

Competition

Competitive Landscape

449 competitors in Non-Small Cell Lung Cancer

#DrugCompanyPhaseTrials

Alecensa

Roche

Approved

22 2

Alunbrig

Takeda

Phase 3

13 3

Iza-Bren

Bristol-Myers Squibb

Phase 3

3 4

TY-9591

TTYK Medicines, Inc

Phase 3

2 5

Remeron

OOrganon and Co

Preclinical

1 6

Treatment

GSK

Preclinical

1 7

Valemetostat Tosylate

Daiichi Sankyo

Preclinical

1 8

Aqupla

Jiangsu Simcere Pharmaceutical Co., Ltd.

Preclinical

—9

Ftorafur

TThe First Affiliated Hospital with Nanjing Medical University

Preclinical

—10

Vibramycin

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Preclinical

—

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

Timeline

Expected Milestones

Q3 2026

Recruiting

Erectile Dysfunction

NCT06532149

Q4 2026

Phase 3Active, not recruiting

Cholangiocarcinoma

NCT04551521

Phase 2Recruiting

Cancer

NCT05159245

Phase 2Active, not recruiting

Adjuvant Treatment

NCT05015010

PreclinicalActive, not recruiting

ALK-Positive Non-Small Cell Lung Cancer

NCT05987956

Post-ApprovalRecruiting

TED

NCT05525338

Clinical

Trials by Indication[1]

Non-Small Cell Lung Cancer22 trials

Phase I/II Trial of Alectinib and Bevacizumab in Patients With Advanced, Anaplastic Lymphoma Kinase (ALK)-Positive, Non-Small Cell Lung Cancer

Terminated·MMassachusetts General Hospital·Phase 1/2·NCT02521051·11 enrolled

A Study of the Efficacy and Safety of Alectinib in Participants With Anaplastic Lymphoma Kinase (ALK)-Rearranged Non-Small Cell Lung Cancer

Completed· Roche logo

Roche·Phase 2·NCT03155009·44 enrolled

A Study to Determine Progression-free Survival (PFS) and Evaluate Participant Experience for Participants With Metastatic Anaplastic Lymphoma Kinase-positive (ALK+) Non-Small Cell Lung Cancer (NSCLC) Treated With Anaplastic Lymphoma Kinase (ALK) Inhibitors

Completed· Takeda logo

Takeda··NCT03546894·111 enrolled

Show 19 more trials

A Study of Alectinib in RET-rearranged Non-small Cell Lung Cancer or RET-mutated Thyroid Cancer

Terminated·—·Phase 1/2·NCT03131206·5 enrolled

Alectinib Versus Pemetrexed or Docetaxel in Anaplastic Lymphoma Kinase (ALK)-Positive Advanced Non-Small Cell Lung Cancer (NSCLC) Participants Previously Treated With Platinum-Based Chemotherapy and Crizotinib

Completed· Roche logo

Roche·Phase 3·NCT02604342·119 enrolled

A Study of Alectinib (CH5424802/RO5424802) in Participants With Anaplastic Lymphoma Kinase (ALK)-Rearranged Non-Small Cell Lung Cancer (NSCLC)

Completed· Roche logo

Roche·Phase 1/2·NCT01871805·134 enrolled

A Phase 1b Study of Atezolizumab in Combination With Erlotinib or Alectinib in Participants With Non-Small Cell Lung Cancer (NSCLC)

Completed· Roche logo

Roche·Phase 1·NCT02013219·52 enrolled

A Study Comparing Alectinib With Crizotinib in Treatment-Naive Anaplastic Lymphoma Kinase-Positive Advanced Non-Small Cell Lung Cancer Participants

Completed· Roche logo

Roche·Phase 3·NCT02075840·303 enrolled

Targeted Treatment for ALK Positive Patients Who Have Previously Been Treated for Non-squamous Non-small Cell Lung Cancer

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT03737994·10 enrolled

A Study of Alectinib (RO5424802) in Participants With Non-Small Cell Lung Cancer Who Have Anaplastic Lymphoma Kinase (ALK) Mutation and Failed Crizotinib Treatment

Completed· Roche logo

Roche·Phase 1/2·NCT01801111·138 enrolled

Anaplastic Lymphoma Kinase (ALK)-Positive Non-small Cell Lung Cancer (NSCLC) Post-alectinib Treatment Patterns

Completed· Pfizer logo

Pfizer··NCT04351334·161 enrolled

A Study to Learn About the Effectiveness of Cancer Medicines in Patients With Metastatic Non-small Cell Lung Cancer in Norway.

Completed· Pfizer logo

Pfizer··NCT05834348·5,279 enrolled

Treatment Registry of Alectinib in Anaplastic Lymphoma Kinase (ALK)-Positive, Locally Advanced or Metastatic Non-Small Cell Lung Cancer in Korea

Completed· Roche logo

Roche··NCT03271554·355 enrolled

Expanded Access Study of Alectinib for Participants With Anaplastic Lymphoma Kinase (ALK)-Rearranged Non-Small Cell Lung Cancer (NSCLC) After Disease Progression on or Intolerance to Prior ALK Tyrosine Kinase Inhibitor Therapy

No longer available· Roche logo

Roche··NCT02271139

Treatment Strategies and Survival Outcome for Non-small Cell Lung Cancer With Oncogenic Mutation

Recruiting·HHunan Province Tumor Hospital·Phase 2·NCT04322890·6,000 enrolled

Monitoring Alectinib Treatment by Detection of ALK Translocations in Serial Blood Samples From Non-Small Cell Lung Cancer Patients

Unknown status·—··NCT04708639·40 enrolled

NAUTIKA1: A Multicenter, Phase II, Neoadjuvant and Adjuvant Study of Multiple Therapies in Biomarker-selected Patients With Resectable Stages IB-III Non-small Cell Lung Cancer

Recruiting· Roche logo

Roche·Phase 2·NCT04302025·99 enrolled

A Phase II/III Multicenter Study Evaluating the Efficacy and Safety of Multiple Targeted Therapies as Treatments for Patients With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) Harboring Actionable Somatic Mutations Detected in Blood (B-FAST: Blood-First Assay Screening Trial)

Active, not recruiting· Roche logo

Roche·Preclinical·NCT03178552·1,000 enrolled

A Phase 3 Study of the Selective Anaplastic Lymphoma Kinase (ALK) Inhibitor NVL-655 Compared to Alectinib in First-Line Treatment of Patients With ALK-Positive Advanced Non-Small Cell Lung Cancer (ALKAZAR)

Recruiting·NNuvalent Inc.·Phase 3·NCT06765109·450 enrolled

A Phase I-II, Multicenter Study Evaluating the Efficacy and Safety of Multiple Therapies in Cohorts of Patients With Resectable Stage I-III Non-Small Cell Lung Cancer, Selected According to Biomarker Status

Completed· Roche logo

Roche·Phase 3·NCT06624059·11 enrolled

A Phase I-III, Multicenter Study Evaluating the Efficacy and Safety of Multiple Therapies in Cohorts of Patients Selected According to Biomarker Status, With Locally Advanced, Unresectable, Stage III Non-Small Cell Lung Cancer

Active, not recruiting· Roche logo

Roche·Phase 3·NCT05170204·68 enrolled

A Single Arm Phase II Trial Evaluating the Activity of Alectinib for the Treatment of Pretreated RET-rearranged Advanced NSCLC

Terminated·EETOP IBCSG Partners Foundation·Phase 2·NCT03445000·14 enrolled

Lung Cancer3 trials

A Study of Brigatinib Compared to Alectinib in Adults With Non-Small-Cell Lung Cancer

Completed· Takeda logo

Takeda·Phase 3·NCT03596866·248 enrolled

Delayed or Upfront Brain RAdiotherapy in Treatment naïve Lung Cancer Patients With Asymptomatic or Minimally Symptomatic Brain Metastases and ALK rEarrangements

Recruiting·JJoshua Palmer·Phase 1/2·NCT05987644·56 enrolled

Phase 2 Platform Study in Patients With Advanced Non-Small Lung Cancer Who Progressed on First-Line Osimertinib Therapy (ORCHARD)

Active, not recruiting· AstraZeneca logo

AstraZeneca·Phase 2·NCT03944772·247 enrolled

Immunotherapy2 trials

Brazilian Lung Immunotherapy Study

Completed·HHospital Israelita Albert Einstein·Phase 2·NCT05081674·154 enrolled

The Rome Trial From Histology to Target: the Road to Personalize Target Therapy and Immunotherapy

Unknown status·FFondazione per la Medicina Personalizzata·Phase 2·NCT04591431·400 enrolled

Treatment2 trials

Study of Precision Treatment for Rare Tumours in China Guided by PDO and NGS

Not yet recruiting·PPeking University Shenzhen Hospital·Phase 2·NCT06692491·200 enrolled

SMMART Adaptive Clinical Treatment (ACT) Trial

Withdrawn·OOHSU Knight Cancer Institute·Phase 1·NCT05238831

Advanced Solid Tumors2 trials

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

My Pathway: A Study Evaluating Herceptin/Perjeta, Tarceva, Zelboraf/Cotellic, Erivedge, Alecensa, and Tecentriq Treatment Targeted Against Certain Molecular Alterations in Participants With Advanced Solid Tumors

Completed· Roche logo

Roche·Phase 2·NCT02091141·673 enrolled

32 more indications

ALK Positive2 trials

DETERMINE Trial Treatment Arm 01: Alectinib in Adult, Paediatric and Teenage/Young Adult Patients With ALK Positive Cancers

Recruiting·CCancer Research UK·Phase 2/3·NCT05770037·30 enrolled

Alectinib in Combination With Bevacizumab in ALK Positive NSCLC

Completed·IInstituto Nacional de Cancerologia de Mexico·Phase 2·NCT03779191·41 enrolled

NSCLC2 trials

Alectinib Pharmacokinetic in Patients With NSCLC

Recruiting·IInstituto Nacional de Cancerologia de Mexico·Phase 1/2·NCT05713006·45 enrolled

A Multicenter Non-Interventional Cohort Study to Evaluate the Real-World Clinical Management and Outcomes of Patients Diagnosed With ALK-Positive Advanced NSCLC Treated With Alectinib (ReAlec)

Active, not recruiting· Roche logo

Roche··NCT04764188·800 enrolled

Solid Tumor2 trials

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

Active, not recruiting· Roche logo

Roche·Phase 2·NCT04589845·920 enrolled

KOrean Precision Medicine Networking Group Study of MOlecular Profiling Guided Therapy Based on Genomic Alterations in Advanced Solid Tumors II

Recruiting·SSeoul National University Bundang Hospital··NCT05525858·1,000 enrolled

Efficacy and Safety1 trial

A Home-Based Approach Study to Evaluate the Efficacy and Safety of Alectinib in Locally-Advanced or Metastatic ALK-Positive Solid Tumors

Terminated· Roche logo

Roche·Phase 2·NCT04644315·1 enrolled

Minimal Residual Disease1 trial

Minimal Residual Disease Guiding Adjuvant Therapy in Stage I NSCLC

Not yet recruiting·GGuangdong Association of Clinical Trials·N/A·NCT06709274·342 enrolled

Resistance1 trial

Deciphering Antitumour Response and Resistance With INtratumour Heterogeneity

Active, not recruiting·UUniversity College, London·Phase 2·NCT02314481·50 enrolled

Advanced1 trial

A Phase IB/II Study of Alectinib Combined With Cobimetinib in Advanced ALK-Rearranged (ALK+) NSCLC

Active, not recruiting·MMassachusetts General Hospital·Phase 1/2·NCT03202940·16 enrolled

Erectile Dysfunction1 trial

ERectile Dysfunctions, gOnadotoxicity and Sexual Health Assessment in Men With Lung Cancer

Recruiting·FFondazione Policlinico Universitario Agostino Gemelli IRCCS··NCT06532149·80 enrolled

Rare Tumor1 trial

PLATFORM Study of Precision Medicine for Rare Tumors

Recruiting·—·Phase 2·NCT04423185·770 enrolled

Oral1 trial

A Study Investigating the Effect of Food and Esomeprazole on the Single Oral Dose Pharmacokinetics of Alectinib (RO5424802) in Healthy Volunteers.

Completed· Roche logo

Roche·Phase 1·NCT02023125·42 enrolled

Cancer of Unknown Primary Site1 trial

A Phase II Randomized Study Comparing the Efficacy and Safety of Targeted Therapy or Cancer Immunotherapy Versus Platinum-Based Chemotherapy in Patients With Cancer of Unknown Primary Site

Completed· Roche logo

Roche·Phase 2·NCT03498521·529 enrolled

Cancer1 trial

The Finnish National Study to Facilitate Patient Access to Targeted Anti-cancer Drugs

Recruiting·HHelsinki University Central Hospital·Phase 2·NCT05159245·250 enrolled

Metastatic Colorectal Cancer1 trial

Study to Investigate Outcome of Individualized Treatment in Patients With Metastatic Colorectal Cancer

Recruiting·OOslo University Hospital·Phase 2·NCT05725200·40 enrolled

Lymphoma1 trial

A Rollover Study of Alectinib in Patients With Anaplastic Lymphoma Kinase (ALK)-Positive or Rearranged During Transfection (RET)-Positive Cancer

Active, not recruiting· Roche logo

Roche·Phase 3·NCT03194893·200 enrolled

Clinical Trial1 trial

ProTarget - A Danish Nationwide Clinical Trial on Targeted Cancer Treatment Based on Genomic Profiling

Recruiting·UUlrik Lassen·Phase 2·NCT04341181·300 enrolled

Anaplastic Large Cell Lymphoma1 trial

A Study of Alectinib and Duvelisib in People With Anaplastic Lymphoma Kinase-Positive Anaplastic Large Cell Lymphoma (ALK+ALCL)

Recruiting·MMemorial Sloan Kettering Cancer Center·Phase 1·NCT07001384·30 enrolled

Tyrosine Kinase Inhibitor1 trial

Real-world Therapy of ALK-positive NSCLC in Sweden: the Sequencing of ALK Tyrosine Kinase Inhibitor Drugs and Their Therapeutic Outcomes Based on Data From National Registers.

Completed· Pfizer logo

Pfizer··NCT04647110·549 enrolled

Hepatic Impairment1 trial

Effect of Hepatic Impairment on the Pharmacokinetics of Alectinib

Completed· Roche logo

Roche·Phase 1·NCT02621047·28 enrolled

Recurrent or Refractory1 trial

Alectinib in Combination With Nivolumab in the Treatment of Recurrent or Refractory HCC Patients Guided With Serum RNase1 and Tumor Expression of PD-L1

Completed·—·Phase 1·NCT06354387·5 enrolled

TED1 trial

Comparison of Standard Dose Alectinib to Alectinib in Adjusted Dose Based on Alectinib Bloodlevels

Recruiting·UUniversity Medical Center Groningen·Phase 4·NCT05525338·196 enrolled

Toxicity1 trial

Alectinib-induced Endocrine Toxicity

Completed·FFondazione Policlinico Universitario Agostino Gemelli IRCCS··NCT06339554·98 enrolled

Trial1 trial

The Drug Rediscovery Protocol (DRUP Trial)

Recruiting·TThe Netherlands Cancer Institute·Phase 2·NCT02925234·1,550 enrolled

Tics1 trial

A Study of the Effects of Posaconazole on Alectinib (RO5424802) Pharmacokinetics in Healthy Volunteers

Completed· Roche logo

Roche·Phase 1·NCT01984229·23 enrolled

Adjuvant Treatment1 trial

Alectinib in Neo-adjuvant Treatment of Stage III NSCLC

Active, not recruiting·GGruppo Oncologico Italiano di Ricerca Clinica·Phase 2·NCT05015010·33 enrolled

Carcinoma, Non-Small-Cell Lung1 trial

Real World Clinical Outcomes of Resected ALK-Positive Early Stage NSCLC Patients Treated With Alectinib as Adjuvant Therapy in China: A Multicenter, Prospective Cohort Study

Recruiting· Roche logo

Roche··NCT06862869·800 enrolled

ALK-positive Non-small Cell Lung Cancer1 trial

Explore the Relationship Between Single Nucleotide Polymorphisms and Alectinib Response and Toxicity in Patients With Non-Small Cell Lung Cancer.

Active, not recruiting·HHan Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair·Preclinical·NCT05987956·600 enrolled

ALK Fusion-positive Solid or CNS Tumors1 trial

A Phase I/II, Open-Label, Multicenter, Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Alectinib in Pediatric Participants With ALK Fusion-Positive Solid or CNS Tumors for Whom Prior Treatment Has Proven to be Ineffective or for Whom There is No Satisfactory Treatment Available

Active, not recruiting· Roche logo

Roche·Preclinical·NCT04774718·42 enrolled

Malignant Solid Tumor1 trial

MegaMOST - A Multicenter, Open-label, Biology Driven, Phase II Study Evaluating the Activity of Anti-cancer Treatments Targeting Tumor Molecular Alterations /Characteristics in Advanced / Metastatic Tumors.

Recruiting·CCentre Leon Berard·Phase 2·NCT04116541·455 enrolled

Haematological Malignancy1 trial

DETERMINE (Determining Extended Therapeutic Indications for Existing Drugs in Rare Molecularly Defined Indications Using a National Evaluation Platform Trial): An Umbrella-Basket Platform Trial to Evaluate the Efficacy of Targeted Therapies in Rare Adult, Paediatric and Teenage/Young Adult (TYA) Cancers With Actionable Genomic Alterations, Including Common Cancers With Rare Actionable Alterations

Recruiting·CCancer Research UK·Preclinical·NCT05722886·825 enrolled

Non-Small Cell Lung Carcinoma1 trial

Randomized, Multicenter, Phase III, Open-Label Study of Alectinib Versus Crizotinib in Asian Patients With Treatment-Naive Anaplastic Lymphoma Kinase-Positive Advanced Non-Small Cell Lung Cancer

Completed· Roche logo

Roche·Phase 3·NCT02838420·187 enrolled

Cholangiocarcinoma1 trial

FIGHT-302: Pemigatinib vs Chemo in FGFR2+ CCA

Active, not recruiting· Incyte logo

Incyte·Phase 3·NCT04551521·432 enrolled

Unspecified2 trials

NCT Neuro Master Match - N²M² (NOA-20)

Completed·UUniversity Hospital Heidelberg·Phase 1/2·NCT03158389·228 enrolled

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

Active, not recruiting· Roche logo

Roche·Phase 3·NCT03768063·1,000 enrolled

Regulatory

FDA Approval Timeline[5]

Dec 11, 2015

ALECENSA

NDA NDA208434

Sources

References

[1]
ClinicalTrials.gov — 67 trial records for Alectinib. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Alecensa drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Alectinib compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Alectinib. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA208434). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Alecensa. 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: EML4-ALK Inhibitor; Tyrosine-Protein Kinase Receptor RET Inhibitor; ALK Tyrosine Kinase Receptor Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Roche

Patent Landscape[6]

Patent Cliff

Jun 9, 2030

Earliest patent expiration — generic entry possible after this date

Patent #Expires

9440922Jun 9, 2030

9126931May 29, 2031

9365514Mar 4, 2032

10350214Apr 24, 2035

11433076Apr 24, 2035

Alecensa

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q3 2026

Q4 2026

Trials by Indication[1]

Non-Small Cell Lung Cancer22 trials

Lung Cancer3 trials

Immunotherapy2 trials

Treatment2 trials

Advanced Solid Tumors2 trials

ALK Positive2 trials

NSCLC2 trials

Solid Tumor2 trials

Efficacy and Safety1 trial

Minimal Residual Disease1 trial

Resistance1 trial

Advanced1 trial

Erectile Dysfunction1 trial

Rare Tumor1 trial

Oral1 trial

Cancer of Unknown Primary Site1 trial

Cancer1 trial

Metastatic Colorectal Cancer1 trial

Lymphoma1 trial

Clinical Trial1 trial

Anaplastic Large Cell Lymphoma1 trial

Tyrosine Kinase Inhibitor1 trial

Hepatic Impairment1 trial

Recurrent or Refractory1 trial

TED1 trial

Toxicity1 trial

Trial1 trial

Tics1 trial

Adjuvant Treatment1 trial

Carcinoma, Non-Small-Cell Lung1 trial

ALK-positive Non-small Cell Lung Cancer1 trial

ALK Fusion-positive Solid or CNS Tumors1 trial

Malignant Solid Tumor1 trial

Haematological Malignancy1 trial

Non-Small Cell Lung Carcinoma1 trial

Cholangiocarcinoma1 trial

Unspecified2 trials

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

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