Pfizer therapy for hard-to-treat blood cancer granted FDA accelerated approval
Pfizer blood cancer
The US Food and Drug Administration (FDA) has granted accelerated approval to Pfizer's therapy for the treatment of a challenging form of blood cancer, the company announced on Monday.
This approval, as per Reuters, hinges on compelling data from a mid-stage study, which revealed that 58 per cent of patients treated with Pfizer's therapy exhibited either no cancer presence or a significant reduction in cancer cells.
Elrexfio
This groundbreaking decision permits the use of Pfizer's therapy 'Elrexfio', in patients dealing with multiple myeloma, a type of blood cancer that is often resistant to conventional treatment and reoccurs even after a patient undergoes four or more rounds of certain classes of treatments, reports Reuters.
The drug, which is administered subcutaneously, or under the skin, is also known as elranatamab, and belongs to the class of bi-specific antibodies — these boost the immune system's ability to target and eliminate cancerous cells by bringing together immune cells with cancer cells.
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For patients in America, the therapy will be sold at $7,556 for the 44 mg vial and $13,051 for the 76 mg vial, according to Pfizer.
The therapy's initial list price, as per the company, is expected to be approximately $41,500 per month. However, Pfizer anticipates that the monthly cost will decrease to around $26,000 as patients transition to bi-weekly dosing.
When will it be available?
Mid-stage trial results indicate that Elrexfio has an average treatment duration of eight months. As per Pfizer, it should be available to patients in the weeks following the FDA approval.
Blood cancer
Multiple myeloma is a prevalent type of blood cancer that originates in the bone marrow. It can metastasise throughout the body.
Patients often experience disease recurrence after discontinuing treatment. Elrexfio may help address this unmet medical need.
Similar antibody therapies in the market include Roche's Columvi, Abbvie's Epkinly, and Johnson & Johnson's recently approved Talvey.
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A distinctive aspect of Elrexfio is its potential for "off-the-shelf" usage. Healthcare providers in hospitals and clinics can administer the therapy on an ongoing basis, enhancing accessibility for patients, said the company.
It is noteworthy that the therapy's approval comes with a boxed warning related to neurologic toxicity and cytokine release syndrome, a condition marked by an intensified immune system response.
(With inputs from agencies)
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