US FDA approves Regeneron's blood cancer therapy
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.
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