Elranatamab

Highest phase reached
Approved
www.ebi.ac.uk
Drug type
Antibody
www.ebi.ac.uk
First approval year
2023
www.ebi.ac.uk

First approval year
2023
www.ebi.ac.uk
Listing at source
Listed
Highest phase reached
Approved
www.ebi.ac.uk

Drug type
Antibody
www.ebi.ac.uk
Drug name
Elranatamab
www.ebi.ac.uk

  • elrexfio
  • Elrexfio

  • anti cd3 anti bcma bispecific monoclonal antibody pf 06863135
  • ANTI-CD3/ANTI-BCMA BISPECIFIC MONOCLONAL ANTIBODY PF-06863135
  • b cell maturation antigen bcma cluster of differentiation 3 cd3 bispecific monoclonal antibody mab anti bcma anti cd3 bispecific mab
  • B-CELL MATURATION ANTIGEN (BCMA) CLUSTER OF DIFFERENTIATION 3 (CD3) BISPECIFIC MONOCLONAL ANTIBODY (MAB) ANTI-BCMA/ANTI-CD3 BISPECIFIC MAB
  • elranatamab
  • Elranatamab
  • Elranatamab (Elra)
  • Elranatamab (PF-06863135)
  • elranatamab [INN]
  • Elranatamab [MI]
  • ELRANATAMAB [USAN]
  • Elranatamab [WHO-DD]
  • elranatamab bcmm
  • Elranatamab bcmm [WHO-DD]
  • elranatamab bcmm who dd
  • Elranatamab injection
  • elranatamab inn
  • elranatamab mi
  • elranatamab usan
  • elranatamab who dd
  • Elranatamab-bcmm
  • Immunoglobulin G2 [224-arginine,265-alanine,330-serine,331-serine], anti-(human CD3 antigen ε-chain) (human-Mus musculus monoclonal PF-06863059 γ2-chain), disulfide with human-Mus musculus monoclonal PF-06863059 κ-chain, (223→217′)(227→221′)(230→224′)-tris(disulfide) with immunoglobulin G2 [218-glutamic acid,259-alanine,324-serine,325-serine] anti-(human B-cell maturation antigen) (human monoclonal PF-06863058 γ2-chain) disulfide with human monoclonal PF-06863058 κ-chain
  • immunoglobulin g2 224 arginine 265 alanine 330 serine 331 serine anti human cd3 antigen ε chain human mus musculus monoclonal pf 06863059 γ2 chain disulfide with human mus musculus monoclonal pf 06863059 κ chain 223 217 227 221 230 224 tris disulfide with immunoglobulin g2 218 glutamic acid 259 alanine 324 serine 325 serine anti human b cell maturation antigen human monoclonal pf 06863058 γ2 chain disulfide with human monoclonal pf 06863058 κ chain
  • immunoglobulin g2 kappa anti homo sapiens t cell surface glycoprotein cd3 epsilon chain cd3e t cell surface antigen t3 leu 4 epsilon chain human mus musculus monoclonal disulfide with immunoglobulin g2 kappa anti homo sapiens tumor necrosis factor receptor superfamily member 17 tnr17 b cell maturation protein cd269 antigen human mus musculus monoclonal disulfide with immunoglobulin g2 kappa γ2 heavy chain anticd3e 1 447 homo sapiens vh ighv3 48 03 84 ighd ighj4 01 86 8 10 12 1 121 homo sapiens ighg2 01 hinge c5 r 224 e7 r 226 p10 r 229 ch2 d35 a 265 a100 s 330 p101 s 331 ch3 k69 r 409 122 447 135 219 disulfide with κ light chain anti cd3e 1 219 v kappa homo sapiens igkv4 1 01 90 igkj2 02 91 mus musculus igkv8 21 01 84 igkj4 01 12 3 8 1 112 homo sapiens igkc 01 113 219 223 217 227 221 230 224 trisdisulfide with γ2 heavy chain anti tnr17 1 441 homo sapiens vh ighv3 23 01 94 ighd ighj1 01 8 8 8 1 115 homo sapiens ighg2 01 hinge c5 e 218 p10 e 223 ch2 d35 a 259 a100 s 324 p101 s 325 ch3 l28 e 362 116 441 129 215 disulfide with κ light chain anti tnr17 1 215 homo sapiens v kappa homo sapiens igkv3 20 01 95 igkj1 01 7 3 9 1 108 homo sapiens igkc 01 109 215
  • Immunoglobulin G2-kappa, anti-(Homo sapiens T-cell surface glycoprotein CD3 epsilon chain CD3E (T-cell surface antigen T3/Leu-4 epsilon chain)), human-Mus musculus monoclonal disulfide with immunoglobulin G2-kappa, anti-(Homo sapiens - Tumor necrosis factor receptor superfamily member 17 TNR17 (B-cell maturation protein; CD269_antigen)), human-Mus musculus monoclonal disulfide with immunoglobulin G2-kappa. γ2 heavy chain antiCD3E (1-447) [Homo sapiens VH (IGHV3-48*03 (84%) –(IGHD)-IGHJ4*01 (86%)) [8.10.12] (1-121) -Homo sapiens IGHG2*01 {hinge[C5>R(224),E7>R(226),P10>R(229)], CH2[D35>A(265), A100>S(330),P101>S(331)], CH3[K69>R(409)]} (122-447)] (135-219')-disulfide with κ light chain anti-CD3E (1'-219') [V-KAPPA (Homo sapiens IGKV4-1*01 (90%)-IGKJ2*02 (91%)/Mus musculus IGKV8-21*01 (84%)-IGKJ4*01) [12.3.8] (1'-112') -Homo sapiens IGKC*01 (113'-219')]; (223-217'':227-221'':230-224'')-trisdisulfide with γ2 heavy chain anti-TNR17 (1''-441'') [Homo sapiens VH (IGHV3-23*01 (94%) –(IGHD)-IGHJ1*01) [8.8.8] (1''-115'') -Homo sapiens IGHG2*01 {hinge[C5>E(218''),P10>E(223'')], CH2[D35>A(259''),A100>S(324''),P101>S(325'')], CH3[L28>E(362'')]} (116''-441'') (129''-215''')-disulfide with κ light chain anti-TNR17 (1'''-215''') [Homo sapiens V-KAPPA (Homo sapiens IGKV3-20*01 (95%) –IGKJ1*01)[7.3.9] (1'''-108''') -Homo sapiens IGKC*01 (109'''-215''')

And 7 more, listed on the interactive page.

ATC classification codes
  • L01FX32
Sources for recorded values
www.ebi.ac.uk
CAS registry numbers
  • 2408850-14-4
ChEMBL ID
CHEMBL4297809
www.ebi.ac.uk
FDA ingredient codes (UNII)
  • L0HR9A577V

  • 2644880
  • 2644881

Applicant
PFIZER INC
Approval date
14 Aug 2023
Application number
BLA761345

Status
Authorised
Status date
7 Dec 2023
Authorisation date
7 Dec 2023
Approved indications
Elrexfio is indicated as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody and have demonstrated disease progression on the last therapy.
Product number
EMEA/H/C/005908
Authorisation holder
Pfizer Europe MA EEIG
Priority medicines scheme
Yes
Generic
No
Biosimilar
No
Generic medicines
0
Biosimilar medicines
0
Advanced therapy
No
Conditional approval
Yes
Additional monitoring
Yes
Accelerated assessment
No
Exceptional circumstances
No

Therapeutic areas

  • Multiple Myeloma
European medicines record
www.ema.europa.eu

Patents
0
Designations
7
Earliest recorded loss of exclusivity
14 Aug 2030
First in class
No
Fast track
Yes
Breakthrough designation
Yes
Orphan designation
No
Priority review
Yes
Orphan exclusivity
No
Accelerated approval
Yes
Availability
Prescription only
Boxed warning
Yes

Pharmacology name
elranatamab
Type
Antibody
Drug name stem
-mab
Approval recorded by Guide to Pharmacology
Yes

Administration routes

  • Parenteral

  • Mechanism
    T cell surface glycoprotein CD3 binding agent
    Action type
    BINDING_AGENT
    Target
    T cell surface glycoprotein CD3
    Protein identifier
    P04234
  • Mechanism
    T cell surface glycoprotein CD3 binding agent
    Action type
    BINDING_AGENT
    Target
    T cell surface glycoprotein CD3
    Protein identifier
    P07766
  • Mechanism
    T cell surface glycoprotein CD3 binding agent
    Action type
    BINDING_AGENT
    Target
    T cell surface glycoprotein CD3
    Protein identifier
    P09693
  • Mechanism
    Tumor necrosis factor receptor superfamily member 17 binding agent
    Action type
    BINDING_AGENT
    Target
    Tumor necrosis factor receptor superfamily member 17
    Protein identifier
    Q02223

  • Mechanism
    T cell surface glycoprotein CD3 binding agent
    Action type
    BINDING AGENT
    Target
    T cell surface glycoprotein CD3
  • Mechanism
    Tumor necrosis factor receptor superfamily member 17 binding agent
    Action type
    BINDING AGENT
    Target
    Tumor necrosis factor receptor superfamily member 17

  • Condition
    Neoplasms
    Highest recorded phase
    4
    Condition identifier
    EFO:0000616
    Subject identifier
    D009369
  • Condition
    Multiple Myeloma
    Highest recorded phase
    4
    Condition identifier
    EFO:0001378
    Subject identifier
    D009101
  • Condition
    Smoldering Multiple Myeloma
    Highest recorded phase
    2
    Condition identifier
    EFO:0003073
    Subject identifier
    D000075122

  • Condition identifier
    EFO_0000616
  • Condition identifier
    EFO_0001378
  • Condition identifier
    EFO_0003073
    Highest recorded phase
    2
  • Condition identifier
    MONDO_0000430
    Highest recorded phase
    1
  • Condition identifier
    MONDO_0005070
    Highest recorded phase
    4
  • Condition identifier
    MONDO_0005235
    Highest recorded phase
    2
  • Condition identifier
    MONDO_0009693
    Highest recorded phase
    4
  • Condition identifier
    MONDO_0015667
    Highest recorded phase
    1
  • Condition identifier
    MONDO_0018881
    Highest recorded phase
    1
  • Condition identifier
    MONDO_0018908
    Highest recorded phase
    1
  • Condition identifier
    MONDO_0019438
  • Condition identifier
    MONDO_0019438
    Highest recorded phase
    1

Warnings

  • Warning
    Black Box Warning

Open Targets warnings

  • Warning
    Black Box Warning
    Country
    United States

Reported adverse events

  • Event
    cytokine release syndrome
    Reports
    3
    Reporting signal score
    15.3875

Dose
76mg
Route
Subcutaneous
How often
Weekly through week 24, then every 2 weeks from week 25 to 48, then every 4 weeks from week 49 onward

  • Administer pre-treatment medications prior to each dose in the ELREXFIO step-up dosing schedule
  • Hospitalize for 48 hours after the first step-up dose, and 24 hours after the second

Prodrug
No
Chirality
Single enantiomer
Inorganic
No
Natural product
No

  • Component
    Glycosylation sites (N)
    Sequence
    Asn-291'''' $ Asn-297
  • Component
    Heavy chain: anti-CD3E
    Type
    Protein
    Sequence
    EVQLVESGGGLVQPGGSLRLSCAASGFTFSDYYMTWVRQAPGKGLEWVAFIRNRARGYTSDHNPSVKGRFTISRDNAKNSLYLQMNSLRAEDTAVYYCARDRPSYYVLDYWGQGTTVTVSSASTKGPSVFPLAPCSRSTSESTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSNFGTQTYTCNVDHKPSNTKVDKTVERKCRVRCPRCPAPPVAGPSVFLFPPKPKDTLMISRTPEVTCVVVAVSHEDPEVQFNWYVDGVEVHNAKTKPREEQFNSTFRVVSVLTVVHQDWLNGKEYKCKVSNKGLPSSIEKTISKTKGQPREPQVYTLPPSREEMTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPMLDSDGSFFLYSRLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSLSPGK
  • Component
    Heavy chain: anti-TNR17
    Type
    Protein
    Sequence
    EVQLLESGGGLVQPGGSLRLSCAASGFTFSSYPMSWVRQAPGKGLEWVSAIGGSGGSLPYADIVKGRFTISRDNSKNTLYLQMNSLRAEDTAVYYCARYWPMDIWGQGTLVTVSSASTKGPSVFPLAPCSRSTSESTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSNFGTQTYTCNVDHKPSNTKVDKTVERKCEVECPECPAPPVAGPSVFLFPPKPKDTLMISRTPEVTCVVVAVSHEDPEVQFNWYVDGVEVHNAKTKPREEQFNSTFRVVSVLTVVHQDWLNGKEYKCKVSNKGLPSSIEKTISKTKGQPREPQVYTLPPSREEMTKNQVSLTCEVKGFYPSDIAVEWESNGQPENNYKTTPPMLDSDGSFFLYSKLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSLSPGK
  • Component
    Glycosylation sites (N)
    Sequence
    Asn-291'' $ Asn-297
  • Component
    Disulfide bridges
    Sequence
    22''-96'' $ 22-98 $ 23'''-89''' $ 23'-94' $ 135'''-195''' $ 139'-199' $ 142''-198'' $ 148-204 $ 215'''-129'' $ 219'-135 $ 217''-223 $ 221''- 227 $ 224''-230 $ 255''-315'' $ 261-321 $ 361''-419'' $ 367-425
  • Component
    Light chain: anti-TNR17
    Type
    Protein
    Sequence
    EIVLTQSPGTLSLSPGERATLSCRASQSVSSSYLAWYQQKPGQAPRLLMYDASIRATGIPDRFSGSGSGTDFTLTISRLEPEDFAVYYCQQYQSWPLTFGQGTKVEIKRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC
  • Component
    Light chain: anti-CD3E
    Type
    Protein
    Sequence
    DIVMTQSPDSLAVSLGERATINCKSSQSLFNVRSRKNYLAWYQQKPGQPPKLLISWASTRESGVPDRFSGSGSGTDFTLTISSLQAEDVAVYYCKQSYDLFTFGSGTKLEIKRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC

  • 0069-2522
  • 0069-4494
  • 63539-252

Related records

Trials (50)

Approved for (2)

In development for (1)

Other linked conditions (1)

Targets (4)