Regeneron's new cancer treatment approved by FDA. What's next for potential patients?

Regeneron's new cancer treatment, Lynozyfic, has been approved by the FDA for adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy. Here's what potential patients should know next:

1. **Accessing the Treatment**: Regeneron is working to make Lynozyfic commercially available as quickly as possible. Patients should contact their healthcare providers or Regeneron directly to inquire about availability and access to the treatment.
2. **Treatment Information**: Lynozyfic is the first FDA-approved bispecific antibody targeting BCMA and CD3. It has been shown to have a 70% objective response rate among participants in the Phase 1/2 LINKER-MM1 trial. The recommended dosing schedule is every two weeks starting from week 14, potentially extending to every four weeks for patients achieving a very good partial response or better after 24 weeks of therapy.
3. **Side Effects and Warnings**: The FDA approval includes a Boxed Warning for risks such as cytokine release syndrome and neurological toxicities, as well as additional warnings regarding infections, neutropenia, liver toxicity, and embryo-fetal harm. Patients should be aware of these potential side effects and discuss them with their healthcare providers.
4. **Cost and Insurance**: Regeneron has set a wholesale acquisition cost of $470 per 5 mg vial and $18,800 per 200 mg vial. Patients should contact their insurance providers to understand coverage and reimbursement for the treatment.
5. **Moving Forward in Treatment**: Regeneron is exploring moving Lynozyfic to earlier lines of therapy, as it can replace many of the existing treatments used as a standard of care. Patients who have received four or more lines of treatment may find Lynozyfic to be a new option in their fight against multiple myeloma.

In conclusion, potential patients should consult with their healthcare providers to determine if Lynozyfic is a suitable option for them, considering their medical history and current treatment status. They should also be prepared to discuss the potential side effects and costs associated with the treatment.