Pfizer Inc. — Elrexfio FDA Review (BLA761345, ORIG 1, 2023)
Pfizer Inc. · 2023 · FDA Review (openFDA) · company profile →
Report summary
The FDA has recommended Accelerated Approval for Pfizer's Elrexfio (elranatamab-bcmm) for adult patients with relapsed or refractory multiple myeloma (RRMM) who have received at least four prior lines of therapy. The Biologics License Application (BLA 761345) received Priority Review. Efficacy data from the single-arm Phase 2 Study C1071003 (MAGNETISSM-3) showed an objective response rate of 57.7% in BCMA-naive patients, with a median duration of response not reached. Key safety concerns include cytokine release syndrome (58%) and neurologic toxicity (59%). Nonclinical studies confirmed elranatamab's cytotoxic activity against myeloma cells and detailed its pharmacokinetic and toxicological profiles, including dose-dependent adverse effects and immunosuppression. The review acknowledges the unmet need in RRMM and the drug's Fast Track, Orphan Drug, and Breakthrough Therapy Designations.
Key findings — cited to the page
| participants with Maximum Grade 3 or 4 AEs | 191 patients | Pool 3 (C1071003, C1071001, C1071002, C1071009) · p.154 |
| Cytokine release syndrome (Grade 3 or 4) | 1 patient | Pool 1 (C1071003) · p.154 |
| Grade 2 CRS in patients with RRMM (12/32/76 mg two step-up regimen) | 13.7 % | elranatamab · p.93 |
| participants with Maximum Grade 3 or 4 AEs | 130 patients | Pool 1 (C1071003) · p.154 |
| participants with Maximum Grade 5 AEs | 50 patients | Pool 3 (C1071003, C1071001, C1071002, C1071009) · p.154 |
| Cytokine release syndrome (all grades) | 106 patients | Pool 1 (C1071003) · p.154 |
| Headache (all grades) | 33 patients | Pool 1 (C1071003) · p.154 |
| Grade 2 CRS in patients with RRMM (44/76 mg single step-up regimens) | 47 % | elranatamab · p.93 |
| Grade 2 CRS incidence rate (4 mg initial dose) | 13.7 % | elranatamab · p.93 |
| Grade 1 CRS rate for third dose and later (4 mg initial dose) | 13 % | elranatamab · p.93 |
| participants with Maximum Grade 5 AEs | 37 patients | Pool 1 (C1071003) · p.154 |
| Hypogammaglobulinemia (all grades) | 24 patients | Pool 1 (C1071003) · p.154 |
Source: Pfizer Inc. ↗ · License: US Government public domain. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Oncology library →