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.

<h2>Elrexfio</h2>

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.&nbsp;

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.

<h2>When will it be available?</h2>

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.

<h2>Blood cancer</h2>

Multiple myeloma is a prevalent type of blood cancer that originates in the bone marrow. It can metastasise throughout the body.&nbsp;

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 &amp; 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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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.

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. Also read | In a worrisome first, scientists detect microplastics in human hearts: Study 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. Also read | Scientists unearth Europe’s oldest lakeside stilt village behind a fortress of defensive spikes 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) WATCH WION LIVE HERE You can now write for wionews.com and be a part of the community. Share your stories and opinions with us here.

Pfizer therapy for hard-to-treat blood cancer granted FDA accelerated approval 

AstraZeneca's cancer drug Calquence has shown initial signs of helping hospitalised COVID-19 patients get through the worst of the disease, as researchers scramble to repurpose existing treatments to help fight the deadly infection.

Results from the preliminary research involving 19 patients, which was backed by the United States National Institutes of Health, encouraged the British drugmaker to explore the drug's new use in a wider clinical trial announced in April.

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Eleven patients had been on oxygen when they started the 10-14 day Calquence course and eight of them could afterwards be discharged, breathing independently, according to results in a paper co-authored by Astra's head of oncology research, Jose Baselga.

Eight patients were on mechanical ventilation when they were put on Calquence, and four of them could be discharged, though one died of pulmonary embolism.

"These patients were in a very unstable situation, they would have had a dire prognosis ... Within one to three days the majority of these patients got better in terms of ventilation and oxygen needs," Astra's Baselga told Reuters.

Severe cases of COVID-19 are believed to be triggered by an over-reaction of the immune system known as cytokine storm and initial research has brought Calquence, and other drugs that suppress certain elements of the immune system, into play.

Autoimmune disease drugs that are being tested for their ability to quell the cytokine storm include Regeneron&nbsp; and Sanofi's Kevzara, Roche's&nbsp;Actemra as well as Morphosys&nbsp;and GlaxoSmithKline's&nbsp;otilimab.

In its approved use, Calquence competes with AbbVie and Johnson &amp; Johnson’s established treatment Imbruvica as a treatment for chronic lymphocytic leukaemia, a common type of adult leukaemia.

AstraZeneca's cancer drug Calquence has shown initial signs of helping hospitalised COVID-19 patients get through the worst of the disease, as researchers scramble to repurpose existing treatments to help fight the deadly infection.

AstraZeneca's cancer drug Calquence has shown initial signs of helping hospitalised COVID-19 patients get through the worst of the disease, as researchers scramble to repurpose existing treatments to help fight the deadly infection. Results from the preliminary research involving 19 patients, which was backed by the United States National Institutes of Health, encouraged the British drugmaker to explore the drug's new use in a wider clinical trial announced in April. Also read: US secures 300 million doses of potential AstraZeneca coronavirus vaccine Eleven patients had been on oxygen when they started the 10-14 day Calquence course and eight of them could afterwards be discharged, breathing independently, according to results in a paper co-authored by Astra's head of oncology research, Jose Baselga. Eight patients were on mechanical ventilation when they were put on Calquence, and four of them could be discharged, though one died of pulmonary embolism. "These patients were in a very unstable situation, they would have had a dire prognosis ... Within one to three days the majority of these patients got better in terms of ventilation and oxygen needs," Astra's Baselga told Reuters. Severe cases of COVID-19 are believed to be triggered by an over-reaction of the immune system known as cytokine storm and initial research has brought Calquence, and other drugs that suppress certain elements of the immune system, into play. Autoimmune disease drugs that are being tested for their ability to quell the cytokine storm include Regeneron and Sanofi's Kevzara, Roche's Actemra as well as Morphosys and GlaxoSmithKline's otilimab. In its approved use, Calquence competes with AbbVie and Johnson & Johnson’s established treatment Imbruvica as a treatment for chronic lymphocytic leukaemia, a common type of adult leukaemia.

AstraZeneca blood cancer drug shows signs of helping COVID-19 patients

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Pfizer therapy for hard-to-treat blood cancer granted FDA accelerated approval

AstraZeneca blood cancer drug shows signs of helping COVID-19 patients