HQ Team
August 15, 2023: The USFDA has granted accelerated approval for Pfizer Inc’s Elrexfio to treat incurable blood cancer, multiple myeloma, that affects plasma cells made in the bone marrow, according to a company statement.
Elrefxfio is used to treat patients with relapsed or refractory multiple myeloma, and who have undergone four lines of therapy earlier. The biospecific antibody treatment is administered under the skin.
Refractory myeloma happens when a patient is non-responsive to therapy or progresses within 60 days of the last line of therapy.
Relapsed myeloma occurs in previously treated persons and progresses after earlier therapy, requiring a new treatment.
The FDA, the US drug regulator, based its approval on the company’s phase II trial, where the overall response rate was 58%, with an estimated 82% maintaining the response for at least nine months.
Cut dosage time
For patients who responded to the treatment, the probability of maintaining it at 15 months was 72%.
The treatment helps the body’s immune system to decimate cancer cells by binding one such cell to an immune cell.
The regulator’s Accelerated Approval Program is designed to shorten the time of FDA review for drugs that treat serious conditions and fill an unmet medical need.
Elrexfio is a BCMA-directed therapy (subcutaneously delivered B-cell maturation antigen) with once-every-other-week dosing for responding patients after 24 weeks of weekly therapy.
It reduces the dosage cost time spent at the clinic and “potentially greater long-term treatment tolerability.”
Incurable blood cancer
Among the 63 patients, who received at least four prior lines of therapy, the overall response rate was 33% after a median follow-up of 10.2 months. Eighty-four percent maintained the response for at least nine months.
“Most multiple myeloma patients will experience relapse or resistance of their disease to treatment, often facing increased symptom burden and lowering their chance of surviving longer with each attempted line of therapy,” said MagnetisMM clinical trial investigator Ajay Nooka.
Multiple myeloma is the second most common type of blood cancer, with over 35,000 new cases of MM diagnosed annually in the US and 176,000 globally.
The disease is an aggressive and currently incurable blood cancer that affects plasma cells made in the bone marrow. Healthy plasma cells make antibodies that help the body fight infection.
About half of those diagnosed with MM won’t survive beyond five years, and most will receive four or more lines of therapy due to relapse.
Relapses inevitable
While disease trajectory varies for each person, relapses are nearly inevitable. The goal of Pfizer’s therapy was to achieve disease control with acceptable toxicity and improved quality of life for the patients.
Elrexfio’s label contains a Boxed Warning for cytokine release syndrome and neurologic toxicity, according to the statement.
It also includes immune effector cell-associated neurotoxicity syndrome, in addition to warnings and precautions for infections, neutropenia, hepatotoxicity, and embryo-fetal toxicity.
Similar antibody therapies such as Talvey, made by Johnson & Johnson, AbbVie Inc., Epkinly, and Roche’s Columvi, were given FDA approval.
