Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 115 |
| INN | Elranatamab |
| Status | Approved |
| Drug code(s) | PF-06863135 |
| Brand name | Elrexfio |
| mAb sequence source | mAb humanized |
| General Molecular Category | Bispecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG2 |
| Light chain isotype | kappa |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | None |
| Target(s) | BCMA, CD3 |
| Indications of clinical studies | Multiple myeloma |
| Primary therapeutic area | Cancer |
| Most advanced stage of development (global) | Approved EU, US |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | December 13, 2017 |
| Start of Phase 2 | February 02, 2021 |
| Start of Phase 3 | October 04, 2021 |
| Date BLA/NDA submitted to FDA | December 19, 2022 |
| Year of first approval (global) | 2023 |
| Date of first US approval | August 14, 2023 |
| INN, US product name | Elranatamab, elranatamab-bcmm |
| US or EU approved indications | Treatment for adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. |
| Company | Pfizer |
| Licensee/Partner | None |
| Comments about company or candidate | Approved in the EU in Dec 2023. On 12 October 2023, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a conditional1 marketing authorisation for the medicinal product Elrexfio2, intended for the treatment of multiple myeloma. On August 14, 2023, the Food and Drug Administration granted accelerated approval to elranatamab-bcmm (Elrexfio, Pfizer, Inc.), a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager, for adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. Approval based on MagnetisMM-3 (NCT04649359), a Phase 2 study. Feb 22, 2023: FDA priority review of BLA announced MAA evaluation started on Jan 26, 2023. Nov 2022: Pfizer Inc. announced its investigational cancer immunotherapy, elranatamab, received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for the treatment of people with relapsed or refractory multiple myeloma July 2022: MagnetisMM-3 is a registration-enabling trial of elranatamab. The trial is still ongoing to the primary endpoint analysis with results expected later this year, which, if positive, would form the basis of potential regulatory filings. NCT05020236 Phase 3 study due to start in Aug 2021. March 2021: EMA PRIME designation granted Feb 17, 2021: Pfizer Inc. announced that the first participant has been dosed in the registration-enabling Phase 2 MagnetisMM-3 study (NCT04649359) of elranatamab (PF-06863135), an investigational B-cell maturation antigen (BCMA) CD3-targeted bispecific antibody, in patients with relapsed/refractory multiple myeloma. NCT04649359 is a Phase 2 Study of PF-06863135 Monotherapy in Participants With Multiple Myeloma Who Are Refractory to at Least One PI, One IMiD and One Anti-CD38 mAb started in Feb 2021. Jan 2021: Elranatamab received Fast Track Designation from the FDA for treatment of patients with multiple myeloma Listed in Pfizer pipeline dated July 29, 2019. NCT03269136 Phase 1 study still recruiting as of Aug 2018 |
| Full address of company | 66 Hudson Boulevard East, New York, NY 10001-2192 USA North America United States of America https://www.pfizer.com/contact |
BCMA-CD3 Bispecific Ab; uses Strop Fab-arm exchange method ((WO2016/166629) CD3 antibody: IgG1RRR: 221R, 228R, K409R or IgG2deltaA-RRRR: 223R, 225R, 228R, K409R; Target antibody: IgG1EEE: 221E, 228E, L368E or IgG2deltaA-EEEE: 223E, 225E, 228E, L368E, Exchange with 1-2 mM GSH). PF-06863135 (PF-3135) is a full-length, humanized, bispecific monoclonal antibody (mAb, IgG2a) targeting BCMA (https://ash.confex.com/ash/2020/webprogram/Paper133355.html)
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |