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Pfizer said that the U.S. Food and Drug Administration on Monday gave fast approval to its medication for treating patients with a particularly challenging kind of blood cancer.
The drug, known as Elrexfio, is now approved for use in patients with multiple myeloma that is difficult to treat or that has returned after receiving four or more prior lines of specific types of medicines.
Elrexfio, also known as elranatamab, is a bispecific antibody therapy that is given subcutaneously and aids the body’s immune system in eliminating malignant cells by bringing an immune cell and a cancer cell together.
According to Pfizer, the list prices for the 44 mg and 76 mg vials of Elrexfio will be $7,556 and $13,051, respectively.
According to the business, the therapy will list for $41,500 per month, but if patients switch to bi-weekly medication, the monthly cost is anticipated to drop to roughly $26,000.
According to Pfizer, the therapy could generate peak sales of more than $4 billion.
In the mid-stage trial, Elrexfio’s typical course of treatment lasted eight months, and the company anticipates that the medicine will be accessible within a few weeks of approval.
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New Hope for Multiple Myeloma Patients
A typical kind of blood cancer called multiple myeloma starts in the bone marrow and can spread to other parts of the body. After stopping treatment, many patients experience relapses, which presents a market opportunity for pharmaceutical companies.
The Roche product Columvi, the Abbvie product Epkinly, and the recently approved Johnson & Johnson product Talvey are other comparable antibody treatments on the market.
According to the company’s announcement on Monday, healthcare professionals in hospitals and clinics can use Elrexfio “off-the-shelf” and continuously administer it to patients.
Data from a mid-stage research, which revealed that 58% of patients treated with Pfizer’s treatment had no symptoms of cancer or had experienced a significant decline in cancer cells in the body, served as the foundation for the FDA’s approval.
In order to incorporate the medicine into patients’ initial lines of treatment, Pfizer said it will continue studying it in ongoing late-stage trials.
The approval of the treatment is accompanied by a boxed warning for neurologic damage and cytokine release syndrome, a disease in which the immune system responds more strongly.
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Source: Reuters
