Lynozyfic wins FDA accelerated approval for treating RRMM adults
Therapy now available in US for patients with hard-to-treat myeloma
Linvoseltamab, now branded as Lynozyfic, has received accelerated approval from the U.S. Food and Drug Administration (FDA) for treating adults with relapsed or refractory multiple myeloma (RRMM), its developer Regeneron Pharmaceuticals announced.
Accelerated approval is a regulatory pathway that allows earlier access to promising therapies for life-threatening conditions — essentially, new treatments that may offer a significant therapeutic advantage over existing ones. This FDA approval helps speed treatment availability for patients with limited options, while full approval remains conditional on the completion of clinical trials confirming the drug’s safety and efficacy.
This decision will now make Lynozyfic available in the U.S. for people with multiple myeloma that has relapsed or is hard to treat, Regeneron stated in a company press release.
Specifically, the therapy is indicated for RRMM patients who have already received at least four other prior lines of treatment, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody, and whose disease nonetheless continued to progress.
In May, Lynozyfic received a similar approval in the European Union for the same indication.
The therapy is a bispecific antibody that helps a type of immune cells called T-cells to recognize and destroy cancerous multiple myeloma cells.
“The FDA approval of Lynozyfic reinforces the strength of our bispecific antibody program as well as our commitment to delivering critical medicines to the cancer community,” said George D. Yancopoulos, MD, PhD, president and chief scientific officer of Regeneron.
Regeneron now offering patient support, assistance program
To support patients who have been prescribed the therapy, Regeneron said it has launched a program dubbed Lynozyfic Surround. It offers financial assistance, insurance support, and educational resources to help guide patients through their treatment journey, according to the company. To learn more, Regeneron invites patients and caregivers to call 1-844-RGN-HEME (1-844-746-4363). No further information about the program has been provided.
Multiple myeloma is a blood cancer that arises when plasma cells, a type of immune cell that normally helps fight infections, start to grow uncontrollably in the bone marrow — the spongy tissue inside bones responsible for making blood cells. These cancerous cells, known as myeloma cells, can build up in multiple areas of the bone marrow, which is why the condition is called multiple myeloma.
Administered intravenously, or into the vein, Lynozyfic is designed to simultaneously bind to BCMA, a protein found on the surface of myeloma cells, and CD3, a protein found on T-cells. This dual binding brings T-cells into direct contact with myeloma cells, helping the immune system recognize and destroy the cancer cells.
Treatment begins with two doses of 5 mg and 25 mg, given a week apart, to reduce the risk of side effects, each followed by a 24-hour hospitalization. Patients then receive weekly 200 mg infusions for 14 weeks, or about three months, followed by dosing every two weeks. Those who respond well to the treatment may transition to monthly dosing.
Diane Moran, interim CEO and senior vice president of strategic planning at the International Myeloma Foundation, called the FDA’s award of accelerated approval for Lynozyfic “a welcome milestone” for the community.
“Even though the number of treatment options for multiple myeloma has expanded in recent years, it remains an incurable disease with considerable unmet need, especially among patients who have undergone multiple lines of treatment,” Moran said.
According to Moran, this approval “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.”
Lynozyfic only available through specialized program due to risks
Due to the risk of serious side effects, Lynozyfic is available only through the Lynozyfic Risk Evaluation and Mitigation Strategy (REMS). Because of these risks, the treatment must be administered by trained healthcare providers with close patient monitoring.
The potential side effects include cytokine release syndrome (CRS) and neurologic toxicities such as immune effector cell-associated neurotoxicity syndrome (ICANS). CRS is an intense immune response that can cause symptoms like fever, low blood pressure, and trouble breathing. ICANS and other neurologic issues may involve confusion, tremors, seizures, or even loss of consciousness.
The FDA’s approval decision was supported by promising data from the ongoing Phase 1/2 LINKER-MM1 trial (NCT03761108), which is assessing the safety and efficacy of the medication in more than 350 adults with RRMM.
With a 70% overall response rate in heavily pre-treated patients, we believe Lynozyfic is poised to potentially become a new standard of care for multiple myeloma.
To date, data from the trial have shown that about 70% of 80 evaluable patients responded to the therapy. Among them, 45% had a complete response, meaning no detectable cancer.
Most patients began responding within one month of starting treatment. While the median time patients stayed in remission hasn’t been reached yet, about 89% were still responding at nine months, and 72% at one year, data show. The trial is still recruiting at sites across the U.S., the EU, Japan, and South Korea.
“With a 70% overall response rate in heavily pre-treated patients, we believe Lynozyfic is poised to potentially become a new standard of care for multiple myeloma,” Yancopoulos said. “Furthermore, given the strength of the data, we are rapidly advancing our broad clinical development program for Lynozyfic — exploring its use in earlier lines of therapy as monotherapy and in novel combinations — as we aim to meaningfully advance care for patients.”
Three other clinical studies evaluating Lynozyfic are now also enrolling patients. The Phase 1 LINKER-MM2 trial (NCT05137054) is testing Lynozyfic in combination with other cancer therapies in people with RRMM. The Phase 3 LINKER-MM3 trial (NCT05730036) is comparing Lynozyfic as a standalone therapy to standard combination treatments for RRMM. Meanwhile, the Phase 1/2 LINKER-MM4 (NCT05828511) is enrolling people with newly diagnosed multiple myeloma who have not yet received treatment.
About the Author
