Delhi, Aug. 16, 2023 (GLOBE NEWSWIRE) -- US Bispecific Antibodies Market & Clinical Pipeline Insight 2028 Report Highlights:
- US Bispecific Antibodies Market Opportunity: > USD 15 Billion By 2028
- FDA Approved Bispecific Antibodies: 11 Antibodies
- Approved Bispecific Antibodies Dosage, Price & Sales Insight
- Bispecific Antibodies Reimbursement Medicare, Medicaid & Drug Specific Policy
- Comprehensive Clinical Insight On Bispecific Antibodies In Pipeline: > 300 Antibodies
- US Bispecific Antibodies Clinical Pipeline Insight By Company, Indication & Phase
- Comprehensive Clinical Insight On Approved Bispecific Antibodies
Download Report: https://www.kuickresearch.com/report-us-bispecific-antibodies-market
After receiving commercial approval from the FDA in mid-August 2023, Pfizer’s elranatamab became the latest bispecific antibody to be approved. Elranatamab will be offered under the brand name Elrexfio for the treatment of multiple myeloma. Elrexfio targets the B-cell maturation antigen (BCMA) on multiple myeloma cells and the CD3 on T-cells by bringing them together to destroy myeloma cells by activating T-cells. As the first off-the-shelf fixed-dose subcutaneous BCMA-directed drug, Elrexfio is expected to hit the US market by the end of 2023. Prior to Elrexfio, Johnson & Johnson gained marketing approval for Talvey, another bispecific antibody for the same indication.
The approval of Talvey was based on results from Pfizer’s phase 2 MagnetisMM-3 study. This non-randomized trial had 187 participants, divided into two cohorts A and B. Cohort A consisted of patients who had not received prior BCMA-directed therapy, while Cohort B had patients who had undergone treatment with BCMA-directed therapies, such as with antibody-drug conjugates or CAR T cells.
Relapsed or refractory multiple myeloma (RRMM) patients who took Elrexfio as their first BCMA-directed medication demonstrated notable responses in cohort A data, with a median latency to first response of 1.2 months. With an estimated 82% of respondents keeping their response for at least nine months, the overall response rate was 58%. This trial helped establish Elrexfio as the first BCMA-directed medication in the US, with fortnightly dosage for responding patients after 24 weeks of weekly therapy,. This means less time spent in the clinic and possibly better long-term treatment tolerability. On the other hand, data from Cohort B revealed a response rate of 33% overall after a median follow-up of 10.2 months, with an estimated 84% of individuals retaining the response for at least nine months.
Cytokine release syndrome (CRS), weariness, reaction at the injection site, diarrhea, upper respiratory tract infection, muscle and joint discomfort, pneumonia, decreased appetite, rash, cough, nausea, and fever were the most frequent side effects of Elrexfio that were seen in the clinical studies. The most frequent laboratory abnormalities in Grades 3 to 4 that were seen were reduced lymphocytes, neutrophils, hemoglobin, white blood cells, and platelets.
Elrexfio is only accessible through a restricted program known as the Elrexfio Risk Evaluation and Mitigation Strategy (REMS), due to the possibility of cytokine release syndrome (CRS) and neurologic toxicity (NT), including immune effector cell-associated neurotoxicity syndrome (ICANS). However, researchers found that the step-up dosing regimen, when paired with acetaminophen, dexamethasone, and diphenhydramine pre-treatment, was beneficial in lowering the incidence and severity of the CRS.
Given that Talvey’s approval for the same indication will make Elrexfio’s market more competitive, the latter is already outperforming Talvey clinically. Elrexfio will likely face competition from another Johnson & Johnson bispecific antibody drug called Tecvayli. However, since the dosage for both Talvey and Tecvayli depends on the weight of the patient, Elrexfio is the easier-to-administer therapeutic option in this case. Thus, it is anticipated that this will have a favorable impact on the market acceptance of Elrexfio when it is introduced to the US market by Pfizer in the upcoming weeks.
Elrexfio was granted accelerated approval by the FDA, which reviewed the drug as part of Project Orbis, an agency-led initiative to provide patients with cancer with earlier access to products in other countries where regulatory submissions may be delayed significantly, irrespective of whether or not the product has received FDA approval. Elrexfio is being tested in two Phase 3 trials that will pit it against active medicines in patients with early-stage illness and those who have had bone marrow transplants. The results of those investigations could be used to convert the accelerated clearance to full clearance.
Therefore, even though the market for Elrexfio looks disadvantageous because of certain well-established market competitors, the drug certainly has advantages over these, which will help it gain a customer base among the global multiple myeloma patient. Being a bispecific antibody, Elrexfio is anticipated to become a standard treatment for multiple myeloma because of its pluses over other treatment modalities.
