A new bispecific antibody called elranatamab is moving closer to the myeloma clinic. With Priority Review status granted this week by the FDA, it is anticipated to be approved some time in 2023. The live Early Access Program (EAP) also allows patients who need the medicine today a way of receiving it prior to the FDA approval.
The FDA's Priority Review process allows for faster reviews on drugs that could offer significant improvements over existing options. The European Medicines Agency (EMA) has also accepted elranatamab’s marketing authorization application (MAA).
The Priority Review was granted based on the ongoing MagnetisMM-3 Phase II study. Patients in the study had been heavily pre-treated with at least three lines of therapy including a proteasome inhibitor, an immunomodulatory drug and an anti-CD38 monoclonal antibody.
With a 10.4 month follow-up, patients had an overall response rate of 61% with an 84% probablility of maintaining the response at nine months. Step-up dosing (giving low to increasing doses of the drug in the first few administrations) helped reduce the rate and severity of common symptoms of cytokine release syndrom (CRS) and neurotoxicity.
Additional elranatamab clinical trials are now open for newly diagnosed patients, using the drug as maintenance therapy after transplant and in use with other myeloma therapies in combination.
Previously, elranatamab was was granted Breakthrough Therapy Designation (November 2022) and Orphan Drug Designation by the FDA and EMA.
For patients who may need to use elranatamab today, there are two ways to receive the drug through two Expanded Access Programs:
In this program ,your doctor needs to make a formal request to use the drug through the PfizerCares program. Ask your doctor to go to the PfizerCares portal online or have him/her send an email to email@example.com. The dotor will enter the request into the system for review and evaluation.
A clinical trial called MagnetisMM-17 is open for patients in the United States and in Canada to receive elranatamab as part of an ongoing clinical trial. Patients must fit the inclusion criteria for the study that includes:
There are currently 30 sites open for this clinical trial.
Click this link to learn more about the Expanded Access Clinical Trial.
about the author
Myeloma survivor, patient advocate, wife, mom of 6. Believer that patients can help accelerate a cure by weighing in and participating in clinical research. Founder of HealthTree Foundation (formerly Myeloma Crowd).