Lynozyfic Shows 70% Response Rate in Heavily Pre-Treated Multiple Myeloma Patients, FDA Grants Accelerated Approval

The FDA granted accelerated approval to Lynozyfic (linvoseltamab-gcpt) for adults with relapsed or refractory multiple myeloma (R/R MM) who have undergone at least four prior therapies.

Developed by Regeneron, Lynozyfic is a new option for patients with few remaining treatment alternatives.

According to the manufacturer, the drug is a bispecific antibody that binds to B-cell maturation antigen (BCMA) on cancerous plasma cells and CD3 on T cells, directing the immune system to attack and destroy multiple myeloma cells.

It’s the first FDA-approved BCMAxCD3 bispecific antibody with a response-adapted dosing schedule, offering a more flexible option for patients who respond well to treatment.

As of July 2, 2025, the wholesale acquisition cost is $470 per 5 mg vial and $18,800 per 200 mg vial.

Multiple myeloma is the second most common blood cancer globally, with more than 187,000 new cases each year.

Regeneron said the organization is working quickly to make the drug available and help eligible patients get started with treatment.

To understand the need for this treatment, it’s critical to be aware of multiple myeloma, as it’s the second most common blood cancer globally, with more than 187,000 new cases each year, according to Regeneron.

In the U.S. alone, over 36,000 new cases are expected in 2025, with approximately 12,000 deaths.

The disease is characterized by the overproduction of malignant plasma cells in the bone marrow, which suppress healthy blood cell production, damage organs, and increase infection risk.

Although there have been approvals of new therapies in recent years, multiple myeloma remains incurable.

Most patients relapse after treatment and develop resistance over time, according to Regeneron.

The newly approved drug is intended for patients who have already been treated with a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody—a patient population with limited remaining options.

Regeneron’s approval is based on compelling clinical trial data that showed Lynozyfic’s strong performance in this difficult-to-treat population.

In the Phase 1/2 LINKER-MM1 trial, which studied the drug in 80 heavily pre-treated patients, 70% achieved an objective response, meaning their cancer shrank or disappeared after treatment.

It was found that 45% of patients experienced a complete response or better. These findings were evaluated by an independent review committee.

The drug also worked quickly: the median time to first response was just under one month with a range of 0.5 to 6 months.

It’s important to note the duration of response had not yet been reached at the time of analysis.

However, researchers estimated that 89% of patients maintained their response at 9 months, and 72% maintained it at 12 months, based on a median follow-up period of 13 months.

These results were reflected in real-world clinical practice, according to one of the trial investigators.
Sundar Jagannath, M.D., network director at Mount Sinai’s Center of Excellence for Multiple Myeloma, shared in a news release, “Lynozyfic demonstrated early, deep and durable responses in heavily pre-treated patients, which I saw firsthand in clinical trials.

Lynozyfic has a convenient response-adapted dosing regimen, which provides the potential to extend time between doses. This is a significant patient-centric advancement that could help reduce treatment burden.”

That flexible dosing begins after an initial step-up phase, which includes two 24-hour hospital stays for safety monitoring.

Starting at week 14, patients can move to every-two-week dosing.

For those who achieve a very good partial response (VGPR) or better after 24 weeks of therapy, dosing can be extended to once every four weeks.

For patients and providers concerned about access, Regeneron has also launched Lynozyfic Surround, a support program that offers financial and educational resources.

Company leaders are optimistic that this drug will not only help patients now but shape future standards of care.

George D. Yancopoulos, M.D., president and chief scientific officer of Regeneron, said in the release that Regeneron is “rapidly advancing our broad clinical development program for Lynozyfic – exploring its use in earlier lines of therapy as monotherapy and in novel combinations.”