A new treatment from Regeneron Pharmaceuticals has been approved by the U.S. Food and Drug Administration (FDA) for patients with a recurring form of blood cancer known as multiple myeloma. This approval marks a significant development for those who have already undergone four or more previous therapies.
The drug, branded as Lynozyfic, is designed to target two specific proteins — BCMA on cancer cells and CD3 on immune T-cells — helping the body’s immune system fight the disease more effectively. It belongs to a class of drugs called bispecific antibodies, which researchers describe as “paradigm shifting” in cancer treatment.
Clinical trial results showed that 70% of patients experienced tumor shrinkage or disappearance, while 45% saw their cancer completely vanish. Because of these promising results, the FDA granted accelerated approval, allowing quicker access to the treatment.
Regeneron announced that it’s working quickly to make Lynozyfic commercially available. The cost has been set at $470 per 5 mg vial and $18,800 per 200 mg vial — pricing that reflects the complexity and potential impact of the treatment.
However, like similar drugs from Johnson & Johnson and Pfizer, Lynozyfic comes with serious warnings. Side effects can include neurologic toxicity and cytokine release syndrome, where the immune system overreacts and causes dangerous symptoms.
Still, the drug’s success could reshape how multiple myeloma is treated in the future. Regeneron is also studying the possibility of using these therapies earlier in the treatment process to replace existing standards of care.
According to the American Cancer Society, over 36,000 people in the U.S. are expected to be diagnosed with multiple myeloma in 2025. Of those, around 4,000 patients may benefit directly from Lynozyfic, especially those who have exhausted other treatment options.
Commentary
This approval shows how quickly cancer therapies are advancing — and how companies like Regeneron are pushing the limits of what’s possible. It also reminds us that innovation often comes at a high price, both financially and medically. For patients with limited options, however, drugs like Lynozyfic can mean the difference between extending life and running out of time. As more bispecific antibodies enter the market, we may be on the brink of a new era in personalized cancer treatment.