Health
Pfizer’s Breakthrough: FDA Grants Accelerated Approval For Innovative Blood Cancer Therapy
(CTN NEWS) – Pfizer revealed on Monday that the US Food and Drug Administration (FDA) has granted accelerated approval to their therapy for a difficult type of blood cancer.
According to Reuters, this decision is based on strong evidence from a mid-stage study. The study showed that 58 percent of patients who received Pfizer’s treatment either had no trace of cancer or experienced a notable decrease in cancer cells.
Pfizer’s Breakthrough: Empowering Multiple Myeloma Patients with ‘Elrexfio’ Therapy
Pfizer’s revolutionary decision allows for the utilization of their therapy called ‘Elrexfio’ in patients contending with multiple myeloma, a type of blood cancer known for its resistance to traditional treatments and tendency to reemerge even after undergoing four or more cycles of specific treatment regimens.
This news comes from a report by Reuters.
The medication, referred to as elranatamab, is administered subcutaneously, meaning it is injected under the skin.
It falls into the category of bi-specific antibodies, which enhance the immune system’s capacity to target and eliminate cancerous cells by bringing together immune cells and cancer cells.
In the United States, patients can acquire this therapy for $7,556 for the 44 mg vial and $13,051 for the 76 mg vial, as stated by Pfizer.
Initially, the therapy is slated to have a list price of approximately $41,500 per month, according to the company. However, Pfizer envisions that the monthly cost will decrease to around $26,000 as patients transition to receiving doses bi-weekly.
When will it become accessible?
Based on mid-stage trial findings, Elrexfio exhibits an average treatment duration of approximately eight months. According to Pfizer, it is expected to be made available to patients in the weeks subsequent to receiving FDA approval.
Addressing Unmet Needs: Elrexfio’s Potential in Treating Multiple Myeloma
Multiple myeloma is a prevalent form of blood cancer that originates within the bone marrow and can potentially spread throughout the body.
Patients often encounter instances of disease recurrence after discontinuing treatment. Elrexfio has the potential to address this unmet medical requirement.
Comparable antibody therapies currently on the market encompass Roche’s Columvi, Abbvie’s Epkinly, and Johnson & Johnson’s recently sanctioned Talvey.
A distinguishing feature of Elrexfio is its capability for “off-the-shelf” utilization. Healthcare providers within hospitals and clinics can administer this therapy on an ongoing basis, thereby augmenting its accessibility for patients, as stated by the company.
It is important to note that the therapy’s approval comes with a boxed warning pertaining to neurologic toxicity and cytokine release syndrome, a condition characterized by an intensified immune system response.
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