The U.S. Food and Drug Administration (FDA) has granted accelerated approval to linvoseltamab-gcpt (brand name Lynozyfic) for adults with relapsed or refractory multiple myeloma. This is a blood cancer affecting plasma cells—a type of white blood cell important for making antibodies.

The approval, announced on July 2, 2025, offers new hope to patients who have failed at least four previous treatment lines, including key drug classes such as proteasome inhibitors, immunomodulatory agents, and anti-CD38 antibodies.

Multiple myeloma is an aggressive cancer with no known cure. According to the International Myeloma Foundation, it accounts for roughly 1% of all cancers worldwide, but its burden is growing in South Asia due to ageing populations and improved detection. India alone records over 12,000 new cases annually (GLOBOCAN 2020 data).

Lynozyfic is a bispecific antibody therapy designed to fight multiple myeloma by engaging the body’s own immune system. It binds simultaneously to two distinct targets: BCMA (B-cell maturation antigen) found on myeloma cells and CD3 present on T-cells, which are key immune cells. By connecting these two targets, Lynozyfic acts as a “T-cell engager”, physically bringing cancer cells and T-cells together. This close contact activates the T-cells to recognise, attack, and kill the cancer cells more effectively, offering a targeted and potent approach to treating the disease.

"Bispecific antibodies are among the most promising treatments in late-stage myeloma because they can redirect the patient’s own immune system to kill cancer cells," Dr S. Vincent Rajkumar, a leading myeloma researcher at Mayo Clinic, explains.

Approval for the treatment was granted based on results from a global clinical trial called LINKER-MM1 (NCT03761108), which enrolled 80 patients with advanced, hard-to-treat disease. In this study, the objective response rate (ORR) was 70%, indicating that 70% of participants experienced measurable tumour shrinkage. Additionally, the duration of response (DOR) data showed that 72% of those who responded were still benefiting from the treatment after 12 months. These findings point to a meaningful benefit for patients who had already received multiple prior therapies. However, it's important to note that the trial excluded individuals who had previously received BCMA-targeted treatments, so its results may not apply to that group.

Patients and doctors must carefully consider the important safety concerns that accompany Lynozyfic's promise as a treatment. The U.S. Food and Drug Administration (FDA) has issued its strongest caution—a “Boxed Warning”—highlighting two major risks.

First is Cytokine Release Syndrome (CRS), an intense immune system reaction. When the immune cells are overly activated, they release large amounts of inflammatory chemicals (cytokines) into the bloodstream. This type of reaction can cause high fever, low blood pressure, and even damage to vital organs. In clinical trials of Lynozyfic, CRS was reported in 46% of patients. Most cases were mild and could be managed with treatment, but the risk of serious complications remains.

Second is neurologic toxicity, also known as immune effector cell-associated neurotoxicity syndrome (ICANS). This involves effects on the brain and nervous system such as confusion, difficulty speaking, seizures, or reduced consciousness. In trials, 54% of patients experienced these neurological side effects. While many cases were mild to moderate, severe (grade 3 or 4) toxicity occurred in 8% of participants, requiring close monitoring and medical intervention.

These warnings aim to ensure that patients, families, and healthcare providers understand both the potential benefits and the serious risks before choosing Lynozyfic as a treatment option.

Because of these dangers, patients can only get the drug through a Risk Evaluation and Mitigation Strategy (REMS) , which ensures hospitals and doctors are prepared to manage side effects.

Access to advanced therapies remains a major challenge across South Asian countries such as India, Bangladesh, Nepal, Sri Lanka, and Pakistan. These healthcare systems often struggle with the high costs of treatment and limited infrastructure needed to deliver complex care. In India, for example, even older myeloma drugs like bortezomib or lenalidomide can cost over ₹1 lakh (approximately USD 1,200) per treatment cycle, placing them out of reach for many patients. Newer options, such as CAR-T cell therapies—a highly personalised and advanced form of cancer treatment—are even less accessible, with costs exceeding ₹3–4 crore (around USD 360,000–480,000). Such treatments are not widely available in the region, underscoring deep inequalities in cancer care and the urgent need for more affordable, locally supported solutions.

While Lynozyfic is not yet approved in South Asia, its approval in the U.S. often triggers evaluation by other regulators. Experts expect it could become available in India in 2–4 years, but pricing, safety monitoring, and hospital readiness will be crucial barriers.

While Lynozyfic represents real progress for patients with few other options, its serious side effects and high costs highlight the gap between medical innovation and healthcare access in South Asia. As cancer rates rise in the region, health policy must address both affordability and delivery of advanced treatments.