On January 31, 2024, the official website of the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) showed that Pfizer (PFIZER) has a new drug application for elranatamab, which targets B-cell maturation antigen (BCMA) and CD3 bispecific antibodyIt has been accepted by the CDE and is proposed for priority review。The proposed indication is for patients with refractory multiple myeloma (RRMM) who have received at least three prior treatments (including a proteasome inhibitor, an immunomodulator, and an anti-CD38 monoclonal antibody).
Previously, in August 2023, elranatamabAccelerated approval from the U.S. FDAfor patients with *** or refractory multiple myeloma.
Elranatamab (code: PF-06863135) is a B-cell maturation antigen (BCMA) and CD3 bispecific antibody that binds to BCMA at one end and CD3 receptor on the surface of T cells with the other, thereby activating T cells to kill BCMA-expressing cancer cells. It is passedSubcutaneous injection**For patients, subcutaneous injection is more convenient than intravenous injection and may slow the development of potential factors such as cytokine release syndrome (CRS).
Product Name:elrexfio
Common Name:elranatamab
Codename:pf-06863135
Target:bcma/cd3
Manufacturer:Pfizer
First Approved in the United States:August 2023.
Time of first approval in China:Not yet approved.
Approved Indications:Multiple myeloma.
Specifications:
76mg/1.9ml(40mg/mlmg/1.1ml(40mg/ml)
Recommended Dosage:Subcutaneous injection, ascending dose 1:12 mg on day 1; Day 4 escalating dose 2: 32 mg; The first** dose was 76 mg on day 8, followed by weekly escalation doses of 76 mg through week 24. At week 25, bi-weekly dosing was started, with a dose of 76 mg**.
Storage conditions:Refrigerate 2 to 8 days.
Clinical data
Previously, the FDA approval of elranatamab was based on the positive results of the Phase II clinical trial MagnetisMM-3.
Data from Cohort A (n=123) of this Phase II clinical trial demonstrated a clinically meaningful response in patients with severely pretreated ** or refractory multiple myeloma who received elranatamab as a first-time BCMA target**.
In patients who had received 4 or more prior lines (n=97), the overall objective response rate (ORR) was, approximatelyof patients maintained sustained remission for at least 9 months.
Data for Cohort B (n=64) showed that among 63 patients who received at least four prior regimens, the ORR was, approximatelyof patients maintained sustained remission for at least 9 months.
In addition, in the long-term efficacy data for Cohort A (n=123) presented at the European Association of Hematology (EHA) in 2023, the objective response rate was，35.0% of patients achieved a complete response (CR) or better (CR).of patients achieved a very good partial response (VGPR) or better. The median follow-up was 14At 7 months, median duration of response (DOR), overall survival (OS), and progression-free survival (PFS) have not been reached. For those who responded, about 72% of patients had sustained remission at 15 months.
In terms of safety, common adverse events include:infection, cytokine release syndrome (CRS), anemia, and neutropenia
Summary
In patients with ** or refractory multiple myeloma, elranatamab induces a deep and durable response with a manageable safety profile.
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