Peringatan Keamanan

There is no information available regarding the acute toxicity and overdose of elranatamab.

Elranatamab

DB15395

biotech approved investigational

Deskripsi

Elranatamab is a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager. It is a humanized immunoglobulin 2-alanine kappa antibody derived from two monoclonal antibodies (mAbs), an anti-BCMA mAb and an anti-CD3 mAb,A261060 each of which contributes one heavy chain and one light chain to drug structure. The resulting 4-chain bispecific antibody is covalently linked via five inter-chain disulfide bonds.L47815 On August 14, 2023, the FDA granted accelerated approval to elranatamab for the treatment of multiple myeloma.L47820 Elranatamab was also approved by the European Commission on December 8, 2023.L50437

Struktur Molekul 2D

Struktur tidak tersedia

Peta Jejaring Molekuler
Legenda: Obat • Target • Gen • Enzim • (Panah → menunjukkan arah efek / relasi) • Transporter • Carrier

Profil Farmakokinetik

Waktu Paruh (Half-Life) The mean (CV%) half-life of elranatamab is 22 (64%) days at a dose of 76 mg.[L47815]
Volume Distribusi The mean (CV%) steady-state volume of distribution of elranatamab was 7.76 L (33%).[L47815]
Klirens (Clearance) The mean (CV%) clearance is 0.324 L/day (100%) following 24 weeks dosing.[L47815]

Absorpsi

Elranatamab exhibits dose-proportional pharmacokinetics over the dose range of 6 to 76 mg, which is 0.079 to 1 times the approved recommended dosage. In subjects who received a weekly dosing of 76 mg over 24 weeks, the maximum concentration of 33.6 mcg/mL was achieved at the end of the weekly dosing regimen. The mean (coefficient of variation CV%) Cmax was 3.8 (94%) mcg/mL at the first full 76 mg dose. At 24 weeks and steady-state, the Cmax was 33.6 (48%) mcg/mL and 20.1 (55%) mcg/mL.L47815 Following subcutaneous administration, the mean bioavailability of elranatamab was 56.2%. The Tmax ranged from three to seven days.

Metabolisme

Elranatamab is expected to be metabolized into small peptides by catabolic pathways.L47815

Rute Eliminasi

Data eliminasi belum tersedia.

Interaksi Obat

0 Data
Tidak ada data.

Target Protein

Tumor necrosis factor receptor superfamily member 17 TNFRSF17
T-cell surface glycoprotein CD3 CD3D

Referensi & Sumber

Artikel (PubMed)
  • PMID: 37434334
    Grosicki S, Bednarczyk M, Kociszewska K: Elranatamab: a new promising BispAb in multiple myeloma treatment. Expert Rev Anticancer Ther. 2023 Jul 20:1-8. doi: 10.1080/14737140.2023.2236303.
  • PMID: 37582952
    Lesokhin AM, Tomasson MH, Arnulf B, Bahlis NJ, Miles Prince H, Niesvizky R, Rodriotaguez-Otero P, Martinez-Lopez J, Koehne G, Touzeau C, Jethava Y, Quach H, Depaus J, Yokoyama H, Gabayan AE, Stevens DA, Nooka AK, Manier S, Raje N, Iida S, Raab MS, Searle E, Leip E, Sullivan ST, Conte U, Elmeliegy M, Czibere A, Viqueira A, Mohty M: Elranatamab in relapsed or refractory multiple myeloma: phase 2 MagnetisMM-3 trial results. Nat Med. 2023 Aug 15. doi: 10.1038/s41591-023-02528-9.
  • PMID: 35626122
    Wu L, Huang Y, Sienkiewicz J, Sun J, Guiang L, Li F, Yang L, Golubovskaya V: Bispecific BCMA-CD3 Antibodies Block Multiple Myeloma Tumor Growth. Cancers (Basel). 2022 May 20;14(10). pii: cancers14102518. doi: 10.3390/cancers14102518.

Contoh Produk & Brand

Produk: 7 • International brands: 0
Produk
  • Elrexfio
    Injection, solution • 40 mg/ml • Subcutaneous • EU • Approved
  • Elrexfio
    Injection, solution • 40 mg/ml • Subcutaneous • EU • Approved
  • Elrexfio
    Injection, solution • 44 mg/1.1mL • Subcutaneous • US • Approved
  • Elrexfio
    Injection, solution • 44 mg/1.1mL • Subcutaneous • US • Approved
  • Elrexfio
    Injection, solution • 76 mg/1.9mL • Subcutaneous • US • Approved
  • Elrexfio
    Solution • 44 mg / 1.1 mL • Subcutaneous • Canada • Approved
  • Elrexfio
    Solution • 76 mg / 1.9 mL • Subcutaneous • Canada • Approved

Sekuens Gen/Protein (FASTA)

Sekuens dimuat saat dibutuhkan agar halaman tetap ringan.
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