J&J Innovative Medicine said its multiple myeloma treatment, Darzalex (ingredient: daratumumab),  received expanded insurance coverage as a first-line therapy in combination with bortezomib, thalidomide, and dexamethasone (DVTd regimen) starting from Feb. 1, 2025. 

Darzalex is a monoclonal antibody targeting the CD38 protein, which is expressed in multiple myeloma cells. It was first approved in Korea in 2017 as a fourth-line monotherapy for relapsed or refractory multiple myeloma. In 2019, it gained reimbursement approval for fourth-line treatment and was later approved for multiple indications in first- and second-line therapy in 2019 and 2020.

Multiple myeloma is a type of blood cancer characterized by the abnormal proliferation of plasma cells in the bone marrow. In Korea, the number of registered multiple myeloma patients has surged to approximately 10,000 as of 2023, more than doubling from 4,441 in 2012. The five-year relative survival rate for multiple myeloma between 2017 and 2021 was 50.1 percent, lower than that of some other cancers.

According to the revised reimbursement criteria by the Ministry of Health and Welfare, effective Feb. 1, newly diagnosed multiple myeloma patients eligible for hematopoietic stem cell transplantation (HSCT) will be able to receive insurance benefits for the combination therapy of Darzalex with DVTd regimen.

The expanded reimbursement is based on clinical evidence from the phase 3 CASSIOPEIA study, which compared the DVTd regimen to the standard bortezomib, thalidomide, and dexamethasone (VTd regimen) in transplant-eligible multiple myeloma patients.

With a median follow-up of 18.8 months, the study showed that the DVTd regimen achieved a stringent complete response (sCR) rate of 29 percent at 100 days post-transplant, compared to 20 percent in the VTd group.

Also, the progression-free survival (PFS) rate at 18 months was 93 percent for the DVTd group, significantly higher than the 85 percent observed in the VTd group. While the median PFS had not yet been reached in either group at the time of analysis, the data suggested a clear survival benefit with the addition of Darzalex.

Further long-term analysis, conducted over a median follow-up of 80.1 months, confirmed the sustained efficacy of the DVTd regimen.

Patients in the DVTd group demonstrated a median PFS of 83.7 months, compared to 52.8 months in the VTd group—showing a more than 30-month advantage in delaying disease progression.

Moreover, while the median overall survival (OS) had not been reached in either group, the DVTd regimen improved OS by 45 percent compared to the VTd regimen.

The most common adverse events in both treatment groups included peripheral sensory neuropathy, constipation, fatigue, peripheral edema, nausea, neutropenia, fever, paresthesia, and thrombocytopenia.

Grade 3 or 4 severe adverse events included neutropenia, lymphopenia, stomatitis, and thrombocytopenia.

“Multiple myeloma is a disease that becomes increasingly difficult to treat upon relapse, making effective first-line treatment crucial,” Professor Min Chang-ki of Hematology at Seoul St. Mary’s Hospital said. “There has been strong demand from the clinical field to improve early treatment accessibility, and we hope that this reimbursement expansion will enhance survival rates in Korea and provide new hope for patients.”

J&J Innovative Medicine Oncology & Rare Disease Business Unit Senior Director Kim Youn-hee also said, “We are delighted to announce the expanded insurance coverage for Darzalex, which has been eagerly awaited by many medical professionals and patients.”

The company will continue to ensure that more patients benefit from our innovative treatments, Kim added.