Biological Therapeuticals
Mary Johnson (han at labome dot com)
Synatom Research, Princeton, New Jersey, United States
DOI
//dx.doi.org/10.13070/mm.en.14.3204
Date
last modified : 2025-05-30; original version : 2024-05-23
Cite as
MATER METHODS 2024;14:3204
Abstract

A select list of FDA-approved biological therapeuticals, excluding cell therapies and gene therapies.

2024
  • December 19, SYMVESS acellular tissue engineered vessel-tyod from Humacyte. SYMVESS is an acellular tissue engineered vessel composed of human extracellular matrix (ECM) that exhibits mechanical and biological activity.
  • July 2, KISUNLA donanemab-azbt from Eli Lilly and Company. Indicated for the treatment of patients with Alzheimer’s disease at mild cognitive impairment or mild dementia stage. Donanemab-azbt is a humanized IgG1 monoclonal antibody directed against insoluble N-truncated pyroglutamate amyloid beta.
  • June 20, PIASKY crovalimab-akkz from Roche Genentech. Indicated for the treatment of patients 13 years and older with paroxysmal nocturnal hemoglobinuria and body weight of at least 40 kg. Crovalimab-akkz specifically binds to the complement protein C5, inhibiting its cleavage, preventing the formation of the membrane attack complex.
  • May 16, IMDELLTRA tarlatamab-dlle from Amgen. Indicated for treatment of adults with extensive-stage small cell lung cancer with disease progression on or after platinum-based chemotherapy. Tarlatamab-dlle is a bispecific DLL3-directed CD3 T-cell engager that binds to DLL3 expressed on the surface of cells, including tumor cells, and CD3 expressed on the surface of T cells.
  • April 22, ANKTIVA nogapendekin alfa inbakicept-pmln from ImmunityBio. Indicated with Bacillus Calmette-Guerin (BCG) for the treatment of adults with BCG-unresponsive nonmuscle invasive bladder cancer with carcinoma in situ with or without papillary tumors. Nogapendekin alfa inbakicept-pmln is an interleukin-15 receptor agonist, consisting of (a) nogapendekin alfa (a human IL-15N72D variant) bound to (b) inbakicept (a dimeric human IL-15R alpha sushi domain / human IgG1 Fc fusion protein).
  • March 13, TEVIMBRA tislelizumab-jsgr from BeiGene. Indicated for treatment of adults with unresectable or etastatic esophageal squamous cell carcinoma after prior systemic chemotherapy that did not include a PD-(L)1 inhibitor. Tislelizumab-jsgr is an antibody blocking the activity of programmed death receptor-1.
  • WINREVAIR sotatercept-csrk from Merck. Indicated for the treatment of adults with pulmonary arterial hypertension (WHO Group 1) to increase exercise capacity, improve WHO functional class and reduce the risk of clinical worsening events. Sotatercept-csrk, an activin signaling inhibitor, is a homodimeric protein consisting of the extracellular domain of the human activin receptor type IIA linked to the human IgG1 Fc domain.
2022
  • January 25, KIMMTRAK tebentafusp-tebn from Immunocore. Indicated for treatment of HLA-A*02:01-positive adults with unresectable or metastatic uveal melanoma. Tebentafusp-tebn is a bispecific T cell receptor CD3 T cell engager. The TCR arm binds to a gp100 peptide presented by human leukocyte antigen-A*02:01 on the cell surface of uveal melanoma tumor cells.
2020
  • December 16, MARGENZATM margetuximab-cmkb from MacroGenics. Indicated, in combination with chemotherapy, for the treatment of adult patients with metastatic HER2­ positive breast cancer who have received two or more prior anti-HER2 regimens, at least one of which was for metastatic disease. Margetuximab-cmkb binds to the extracellular domain of the human epidermal growth factor receptor 2 protein. In vitro, the modified Fc region of margetuximab-cmkb increases binding to activating Fc receptor FCGR3A (CD16A) and decreases binding to inhibitory Fc receptor FCGR2B (CD32B).
2014
  • September 4, KEYTRUDA pembrolizumab. from Merck. Pembrolizumab is a monoclonal antibody that binds to the PD-1 receptor and blocks its interaction with PD-L1 and PD-L2.
Declarations
ISSN : 2329-5139