Elrexfio(elranatamab-bcmm)
Oncology· 562 cited findings· 1 source document
Company: Pfizer Inc. →
What the regulatory reviews say
Elrexfio (elranatamab-bcmm) is a drug that underwent regulatory review under BLA 761345, receiving Priority Review status. The application was submitted and received on December 19, 2022, with a PDUFA Goal Date of August 19, 2023, and a Review Completion Date of August 9, 2023.
In efficacy trials, Elrexfio demonstrated an Overall Response Rate (ORR) by BICR of 75% (61.0) and an Objective Response Rate (ORR) of 57.7%. A Stringent Complete Response (sCR) was observed in 16% (13.0) of participants, with a Complete Response (CR) in 18% (14.6) and Very Good Partial Response (VGPR) in 34% (27.6). The median Duration of Response (DOR) was not reached, with a DOR rate at 6 months of 90.4% and at 9 months of 82.3%. A separate finding reported a DOR of 3.8 months.
Safety findings included a Cytokine release syndrome (CRS) incidence of 58%, with 43% occurring after the first step-up dose, 19% after the second step-up dose, and 7% after the first treatment dose. Neurologic toxicity incidence was 59%, including headache (18%), encephalopathy (14%), motor dysfunction (13%), and sensory neuropathy (13%). Guillain-Barre Syndrome incidence was 0.5%.
Key figures — cited to the source page
| Overall Response Rate (ORR) by BICR | 75 (61.0) % | Pfizer Inc. — Elrexfio FDA Review (BLA761345, ORIG 1, 2023), p.122 |
| Stringent Complete Response (sCR) | 16 (13.0) % | Pfizer Inc. — Elrexfio FDA Review (BLA761345, ORIG 1, 2023), p.122 |
| Median Duration of Response (DOR) | not reached | Pfizer Inc. — Elrexfio FDA Review (BLA761345, ORIG 1, 2023), p.28 |
| DOR rate at 9 months | 82.3 % | Pfizer Inc. — Elrexfio FDA Review (BLA761345, ORIG 1, 2023), p.28 |
| Cytokine release syndrome (CRS) incidence | 58 % | Pfizer Inc. — Elrexfio FDA Review (BLA761345, ORIG 1, 2023), p.31 |
| Neurologic toxicity incidence | 59 % | Pfizer Inc. — Elrexfio FDA Review (BLA761345, ORIG 1, 2023), p.31 |
| Application Type | Original BLA | Pfizer Inc. — Elrexfio FDA Review (BLA761345, ORIG 1, 2023), p.4 |
| Review Priority | Priority | Pfizer Inc. — Elrexfio FDA Review (BLA761345, ORIG 1, 2023), p.4 |
Source documents
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Figures are as stated in the cited regulatory review documents (different drugs are studied in different trials — values are not head-to-head comparisons). Educational reference only — not medical or investment advice.