Last update 21 Oct 2026

Ficerafusp alfa

Overview

Basic Info

Drug Type
Monoclonal antibody, Antibody fusion proteins
Synonyms
EGFR/TGFβ fusion monoclonal antibody, BCA 101
Action
antagonists, inhibitors
Mechanism
EGFR antagonists(Epidermal growth factor receptor erbB1 antagonists), TGF-β inhibitors(Transforming growth factor beta inhibitors)
Inactive Indication-
Originator Organization
Active Organization
Inactive Organization-
License Organization-
Drug Highest PhasePhase 2/3
First Approval Date-
RegulationBreakthrough Therapy (United States)
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
D12768---

R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
PD-L1-positive head and neck squamous cell carcinomaPhase 3
United States
28 Jan 2025
PD-L1-positive head and neck squamous cell carcinomaPhase 3
Japan
28 Jan 2025
PD-L1-positive head and neck squamous cell carcinomaPhase 3
Argentina
28 Jan 2025
PD-L1-positive head and neck squamous cell carcinomaPhase 3
Australia
28 Jan 2025
PD-L1-positive head and neck squamous cell carcinomaPhase 3
Austria
28 Jan 2025
PD-L1-positive head and neck squamous cell carcinomaPhase 3
Belgium
28 Jan 2025
PD-L1-positive head and neck squamous cell carcinomaPhase 3
Brazil
28 Jan 2025
PD-L1-positive head and neck squamous cell carcinomaPhase 3
Canada
28 Jan 2025
PD-L1-positive head and neck squamous cell carcinomaPhase 3
Czechia
28 Jan 2025
PD-L1-positive head and neck squamous cell carcinomaPhase 3
France
28 Jan 2025
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2/3
PD-L1-positive head and neck squamous cell carcinoma
First line
PD-L1-positive | HPV-negative
650
ampakbdhif(gcuohpvasm) = mnxguueuuk ephsuxaunf (lyrgqzzxod )
Positive
23 Oct 2026
ampakbdhif(taokjrxmzt) = kfnnckgaiz yzxoavitix (zwdxyxnsad )
Phase 1
Squamous cell carcinoma of head and neck metastatic
First line
PD-L1 | HPV-negative | HPV-positive
42
gdupftmsdt(krjdprgitk) = jdwbrjkqyl aofbmkgqqw (kqdiosxmbu )
Positive
20 Jun 2026
yikazmmrqp(ogkjstwthl) = zgeegyrsaq goetxhxqpv (zqitusrfki )
Phase 2/3
PD-L1-positive head and neck squamous cell carcinoma
First line
PD-L1-positive | HPV-negative
650
kfaiqcbrvy(zimjwtrmyf) = jlvnqaewva jigmmwnnai (qxbvephjiz )
Positive
29 May 2026
Placebo + Pembrolizumab
kfaiqcbrvy(zimjwtrmyf) = qizatpvisl jigmmwnnai (qxbvephjiz )
Phase 1
Squamous Cell Carcinoma of Head and Neck
PD-L1 Expression (CPS >= 1)
31
Ficerafusp alfa 750 mg QW + pembrolizumab 200 mg Q3W
qglzzhxqvk(wjvjundfho) = The most frequent TRAEs (any grade) were acneiform dermatitis (84%), pruritus (45%) and fatigue (39%). wlhldrxnmt (comcjqnrlf )
Positive
05 Dec 2025
Phase 1
Squamous Cell Carcinoma of Head and Neck
First line
human papillomavirus (HPV)-negative
28
(HPV-negative)
aflktzbqsz(usmknioyss) = ppfxyuykhe tejdchxgxa (iqxiezwknd )
Positive
12 Aug 2025
Phase 1
42
ljctpozdrn(wgsfvujqpd) = ppjjysyjem apgjnqucgy (eaeoaqiklp, 37 - 70)
Positive
30 May 2025
ljctpozdrn(wgsfvujqpd) = catyehksdt apgjnqucgy (eaeoaqiklp, 44 - 81)
Phase 1
Advanced Skin Squamous Cell Carcinoma
Second line
anti-PD-1 therapy | anti-EGFR antibodies
14
yqezgbtbhm(zzgabezbyq) = xpnoennlzf iwuosrwtpc (vheiodgtei, 15.2 - 72.3)
Positive
28 Apr 2025
Phase 1
Anal canal squamous cell carcinoma
Second line | Third line
28
vvkuuqxesm(qenmjggveo) = the most common TRAE of any grade including, acneiform dermatitis (16/28 patients; 57.1%), epistaxis (14/28 patients; 50.0%), and pruritus (13/28 patients; 46.4%). iyokdbdram (vwphwlfppw )
Positive
27 Jan 2025
Phase 1
Anal canal squamous cell carcinoma
Second line | Third line
26
fdtfgtddxg(ghpalmeoxr) = rvtmtiearw djjqpvjdqm (fzlusidgjw )
Positive
23 Jan 2025
Phase 1
39
elzjyhomsq(soyfhpyujl) = acneiform rash (76%, with majority being Grade 1/2 in severity), fatigue (43%), and hypophosphatemia (38%). tdgpnolvpc (huonogdzrw )
Positive
27 Jun 2024
Ficerafusp alfa (BCA101) + Pembrolizumab
(HPV-negative)
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Clinical Trial

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Approval

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.
Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

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