Latest news with #Elrexfio
Leaders
4 days ago
- Health
- Leaders
SFDA Approves Elrexfio for Multiple Myeloma Treatment
The Saudi Food and Drug Authority (SFDA) has approved the registration of Elrexfio (Elranatamab) for adult patients with relapsed or refractory multiple myeloma who have undergone at least four prior lines of therapy. These previous treatments must have included a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. Elrexfio has been granted orphan drug designation under the SFDA Orphan Drug Designation Program. How Elrexfio Works? Elrexfio contains Elranatamab, a bispecific antibody designed to target: BCMA – a protein found on multiple myeloma cells CD3 – a receptor on T-cells By binding to both targets, Elrexfio activates T-cells to release immune signals (cytokines) and directly destroy malignant myeloma cells. SFDA's decision followed a thorough evaluation of Elrexfio's efficacy, safety, and quality according to regulatory standards. Clinical trial data showed: 58% overall response rate in patients with relapsed or refractory multiple myeloma after at least four prior lines of therapy 82% of responders maintained their response for at least nine months Dosage, Administration Elrexfio is administered as a subcutaneous injection: Three step-up doses in the first week Once-weekly dosing up to Week 24 Once every two weeks thereafter Safety Profile The most common side effects observed in clinical studies included: Cytokine release syndrome (CRS) Injection site reactions Respiratory tract infections Musculoskeletal pain Fatigue Diarrhea Commitment to Rare Disease Treatment This approval reflects SFDA's commitment to improving access to therapies for rare and hard-to-treat conditions through the Orphan Drug Designation Program. In Saudi Arabia, a rare disease is defined as affecting fewer than 5 people per 10,000 in the population. For more details about the Orphan Drugs Guideline, visit: SFDA Orphan Drugs Guideline Or contact SFDA at: [email protected] Related Topics : SFDA Reports Record 82% Surge in Licensed Factories, Warehouses in 2024 Is wheat harmful to the intestine? SFDA clarifies the truth New Corona vaccines to arrive at the Kingdom: SFDA SFDA: National Biotechnology Strategy Highlights Saudi Leadership in Medical Innovation Short link : Post Views: 7 Related Stories
The Hindu
04-07-2025
- Business
- The Hindu
US FDA approves Regeneron's blood cancer therapy
Regeneron Pharmaceuticals said on Wednesday the U.S. Food and Drug Administration has approved its drug for a type of blood cancer called multiple myeloma that has recurred in patients who had received at least four other therapies earlier. Shares of the company rose 2% following the approval. The company said it is "working diligently" to make the therapy, branded Lynozyfic, commercially available as quickly as possible, and has set a wholesale acquisition cost of $470 per 5 mg vial and $18,800 per 200 mg vial. The accelerated approval was based on a mid-stage trial, in which 70% of patients on Lynozyfic saw their cancer shrink or disappear, while 45% achieved a complete disappearance of their cancer. Lynozyfic is a type of drug called monoclonal antibody that works by targeting two proteins - one found on myeloma cells known as BCMA and another one found on immune T-cells called CD3. These so-called "bispecific antibodies" are "paradigm shifting," Andres Sirulnik, Regeneron's clinical development head for hematology, said. Regeneron is exploring moving such drugs to earlier lines of therapy as they can replace many of the existing treatments used as a standard of care, Sirulnik added. Other bispecific antibodies approved for multiple myeloma are Johnson & Johnson's Tecvayli and Pfizer's Elrexfio. Like Elrexfio and Tecvayli, Lynozyfic comes with a boxed warning for neurologic toxicity and cytokine release syndrome, a condition where the immune system reacts more aggressively. Over 36,000 new cases of multiple myeloma are estimated to be diagnosed in the U.S. in 2025, according to the American Cancer Society. Regeneron estimates about 4,000 new cases will be among those who have received four or more lines of treatment.
Yahoo
03-07-2025
- Business
- Yahoo
Regeneron nabs dosing edge with Lynozyfic's FDA approval in multiple myeloma
Regeneron has won US Food and Drug Administration (FDA) approval for Lynozyfic (linvoseltamab-gcpt), marking the entry of another BCMAxCD3 bispecific drug in the multiple myeloma (MM) treatment space. Via an accelerated approval, Lynozyfic is indicated to treat adult patients with relapsed or refractory multiple myeloma (r/r MM) who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti‑CD38 monoclonal antibody. Regeneron's drug joins two fellow BCMAxCD3 bispecific antibodies already at market in the US – Johnson & Johnson's (J&J) Tecvayli and Pfizer's Elrexfio. Despite playing catch-up with its rivals, Regeneron's product offers a dosing advantage. Lynozyfic, which stimulates T-cells to recognise and destroy cancer cells, can be administered monthly after 24 weeks of therapy, depending on how well the patient responds. Meanwhile, J&J's Tecvayli can be given every two weeks in patients who show a good response after at least six months, and Elrexfio has the same dosing interval from week 25 onward. Lynozyfic also has a fortnightly dosing schedule for patients starting from week 14. Regeneron's Phase I/II Linker-MM1 trial (NCT03761108) with Lynozyfic demonstrated an objective response rate of 70% in 80 patients with MM. Tecvayli and Elrexfio had response rates of 63% and 56% in their respective trials, though direct comparisons are difficult to draw without a head-to-head study. Boxed warnings are common for T-cell directing drugs, and Lynozyfic is no different. It comes with one for cytokine release syndrome (CRS) and neurologic toxicity – including immune effector cell-associated neurotoxicity syndrome – in addition to warnings and precautions for infections, neutropenia, hepatotoxicity and embryo-foetal toxicity. It is unclear how Regeneron will challenge J&J and Pfizer in MM, who both reached the market first but have less convenient dosing options. Justin Holko, Regeneron's senior vice-president for global oncology/haematology commercial business, told Pharmaceutical Technology: 'We don't comment on sales figures or market share, but believe Lynozyfic has the potential to provide significant benefit to multiple myeloma patients, society and the healthcare system.' Tecvayli generated $549m in 2024 while Elrexfio secured $133m. MM is the second most common blood cancer, and revenue for these drugs is expected to skyrocket. Tecvayli, for example, is forecast to reach nearly $4.5bn in annual sales by 2031, according to GlobalData's Pharma Intelligence Center. Similar analysis predicts Lynozyfic will generate $707m in sales by that year, a lower figure primarily due to Regeneron's later market entry. International Myeloma Foundation's interim CEO Diane Moran said: '[Lynozyfic] provides appropriate multiple myeloma patients and their care teams with a novel patient-centric treatment option that includes a dosing schedule that can be adapted based on patient response. We appreciate Regeneron's continued research to further advance treatment for this community.' "Regeneron nabs dosing edge with Lynozyfic's FDA approval in multiple myeloma" was originally created and published by Pharmaceutical Technology, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site.
