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FDA Approves Immunotherapy and Targeted Therapy Combo for Multiple Myeloma

The Food and Drug Administration (FDA) approved a treatment combination for people with multiple myeloma that has recurred or stopped responding to therapy. With the approval, doctors can use two existing treatments together: Tecvayli (teclistamab), a bispecific monoclonal antibody that directs T cells to myeloma cells, and Darzalex Faspro (daratumumab hyaluronidase), an injectable version of the intravenous drug Darzalex (daratumumab), which targets a protein expressed by many melanoma cells. The FDA based the approval on results of a phase III clinical trial, which were published Dec. 9, 2025, in the New England Journal of Medicine. In the trial, 587 people with multiple myeloma who had received one to three previous therapies received Darzalex Faspro, Healio reported. Half also received Tecvayli, while the other half received standard care, which consisted of either the immunomodulatory drug Pomalyst (pomalidomide) with the corticosteroid dexamethasone or the targeted therapy Velcade (bortezomib) with dexamethasone. The estimated three-year overall survival rate was 83.3% for people who received Tecvayli, compared with 65% for those who had standard care. Additionally, the estimated three-year progression-free survival rate was 83.4% for people who received Tecvayli, compared with 29.7% for those in the other group. Researchers reported 70.7% of people who received the Tecvayli-Darzalex Faspro combination experienced serious side effects, such as pneumonia, diarrhea, and low levels of red and white blood cells. “The option to use this regimen as early as second line is particularly important because patients with [multiple myeloma] often experience multiple relapses and reduced responsiveness to therapy over time, which makes earlier treatment with the most effective therapies critical,” Luciano J. Costa, a study author and a hematologist-oncologist at the University of Alabama at Birmingham O’Neal Comprehensive Cancer Center, said in a press release.

Sentinel Node Biopsy Linked to Lower Mortality Risk in Melanoma

People newly diagnosed with melanoma who underwent sentinel node biopsy had a lower risk for cancer-related death than people who did not have the procedure, according to a review published in Lancet Oncology. Doctors typically recommend that people with melanomas considered high risk based on how far they have grown into the skin undergo sentinel node biopsy to determine if the cancer has spread beyond the initial site and may require more aggressive treatment. In this procedure, a surgeon injects a dye into the tumor that then drains to the closest lymph node, which the surgeon removes and tests for cancer cells. However, some oncologists argue patients can skip the procedure and its accompanying side effects, such as pain and fluid buildup, and that people with advanced cancer or a recurrence can receive immunotherapy instead, MedPage Today reported. In the review, researchers analyzed results from 13 studies that included 40,287 people with melanoma. Across the studies, people who underwent sentinel node biopsy had a 14% lower risk for death from melanoma than those who did not have the procedure. Additionally, results from nine of the studies showed people who had sentinel node biopsy had a 29% lower risk for cancer recurrence. In an accompanying commentary, Simone Ribero and Pietro Quaglino, dermatologists at the University Hospital of Turin in Italy, wrote sentinel node biopsy remains an effective option for people with melanoma. “Some authors have objected that this surgical procedure is costly, causes morbidity, and can be replaced by a combination of clinical, pathological, and molecular features,” they wrote. “Nevertheless, no other method has been shown to be able to properly replace [sentinel node biopsy] in terms of sensitivity and specificity.”

Drug Used to Treat Soft Tissue Cancer, Lymphoma Withdrawn From Market

The drugmaker Ipsen has discontinued development of the targeted therapy drug Tazverik (tazemetostat) after clinical trial results raised safety concerns, including that the drug could increase patients’ risk for a second cancer. In January 2020, the Food and Drug Administration (FDA) granted Tazverik accelerated approval for use in certain adults and children with advanced epithelioid sarcoma, a rare and aggressive soft tissue cancer. In June 2020, the FDA granted the drug accelerated approval for use in adults with EZH2-positive follicular lymphoma that had recurred or not responded to other treatments. The FDA grants accelerated approval based on surrogate endpoints, such as response rate or progression-free survival, which are early measures that suggest clinical benefit. However, the FDA requires additional clinical trials to see if the drug prolongs survival, improves quality of life or extends remission. In a confirmatory phase III clinical trial, people with follicular lymphoma received the immunomodulatory drug Revlimid (lenalidomide) and the targeted therapy rituximab with either Tazverik or a placebo. In early results, people who received Tazverik had increased risks for side effects, including a second cancer, Oncology News Central reported. “Emerging data from this confirmatory study have highlighted a safety profile that is unfavorable compared to that previously observed in clinical evaluation,” Christelle Huguet, the head of research and development for Ipsen, which produces the drug, said in a press release. The drugmaker has stopped the clinical trial and all other trials involving Tazverik.