Asset profile

Sevabertinib

Small molecule

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Approvedregulatory verdict

Evidence outlook

Approved: locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) whose... (FDA)

This approval is for an indication outside this terminal's covered markets; the covered program shown here is investigational. Regulatory approval supersedes design-level evidence grading for the approved use.

Source for the program status

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Competitive landscape

63 competitors in this universe: 3 direct rivals (same mechanism and indication), 0 same-class, 60 same-indication; 59 further along in development.

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DrugStageModalityMechanismEvidence signalReported efficacygraded featured trials
Sevabertinib: this drugPhase 3Small moleculeEGFR/HER2
NeratinibApprovedSmall moleculeEGFR/HER2
ORIC-114Phase 1/2Small moleculeEGFR/HER2
STX-721Phase 1/2Small moleculeEGFR/HER2
Afatinib (Gilotrif)ApprovedSmall moleculeEGFR/HER1, HER2, HER4
Alectinib (Alecensa)ApprovedSmall moleculeALK
Alymsys (bevacizumab-Maly)ApprovedMonoclonal antibodyVEGF-A
AmivantamabApprovedMultispecific antibodyEGFR x c-MET
AtezolizumabApprovedMonoclonal antibodyPD-L1
BAT1706 (Avzivi)ApprovedMonoclonal antibodyVEGF-A
BAY2927088 (Hyrnuo)ApprovedSmall moleculeHER2 (ERBB2) exon 20 insertions and point mutations; also mutant-selective EGFR
BevacizumabApprovedMonoclonal antibodyVEGF-A, Vascular Endothelial Growth Factor Inhibitor
Bevacizumab-Awwb (MVASI)ApprovedMonoclonal antibodyVEGF-A
BinimetinibApprovedSmall moleculeMEK1/2
BrigatinibApprovedSmall moleculeALK
CapmatinibApprovedSmall moleculeMET

…and 48 more. Research shows the complete landscape.

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Research adds each competitor's evidence grade and sourced trial results, aligned per race, so you can see who actually has the data.

Upcoming events

(2 total)

Estimated primary-completion dates from ClinicalTrials.gov. These are registry estimates, never confirmed readout dates; they can move as trials progress.

2027 (1)
October 2027 (1)
Phase 3Non-Small Cell Lung CancerRecruiting
Est. primary completion 2027-10-28 · NCT06452277 · CT.gov ↗
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2029 (1)
February 2029 (1)
Phase 2Advanced Solid Tumors, HER2 MutationRecruiting
Est. primary completion 2029-02-02 · NCT06760819 · CT.gov ↗
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See the full readout calendar ↗

All registered studies

Every ClinicalTrials.gov study of this drug's own program, grouped by indication and phase. Research unlocks the studies themselves: titles, statuses, dates and featured-trial cross-links.

Phase 3 (1)
Phase 2 (1)
Phase 1 (2)
Appears in other studies (6)