Johnson & Johnson’s Subcutaneous Darzalex Faspro Combination Receives FDA Approval; Immix Biopharma and Biogen Secure Breakthrough Therapy Designations for Autoimmune Therapies

Johnson & Johnson's Monoclonal Antibody Subcutaneous Injection Combination Therapy Receives FDA Approval Again

Recently, the U.S. FDA approved Johnson & Johnson's CD38-targeted monoclonal antibody Darzalex Faspro (daratumumab and hyaluronidase) subcutaneous injection formulation in combination with bortezomib, lenalidomide, and dexamethasone (VRd regimen) for the treatment of newly diagnosed adult patients with multiple myeloma who are not eligible for autologous hematopoietic stem cell transplantation (ASCT).

This approval is mainly based on the efficacy data from the CEPHEUS study. This is an open-label, randomized, active-controlled clinical trial, enrolling newly diagnosed multiple myeloma patients who are ineligible for or refuse ASCT as initial treatment. The study randomized a total of 395 patients, with 197 receiving Darzalex Faspro in combination with VRd and 198 receiving VRd alone. The primary efficacy endpoints included the overall minimal residual disease (MRD) negativity rate and progression-free survival (PFS) assessed by an independent review committee (IRC) according to the International Myeloma Working Group (IMWG) criteria. The results showed,The MRD-negative rate in the Darzalex Faspro group was 52.3%, higher than 34.8% in the VRd group (p=0.0005); the PFS hazard ratio was 0.60 (95% CI: 0.41-0.88; p=0.0078).The efficacy of this combination therapy in patients who refuse ASCT as initial treatment has not been established.

Autologous Immune CAR-T Therapy Receives FDA Breakthrough Therapy Designation

Immix Biopharma Announces FDA Grants Breakthrough Therapy Designation (BTD) to NXC-201 for Relapsed/Refractory AL Amyloidosis

NXC-201 is a stericity-optimized BCMA-targeted chimeric antigen receptor T-cell (CAR-T) therapy., which is designed to reduce non-specific activation, thereby improving the precision and safety of the treatment. This therapy works by guiding the immune system to identify and eliminate the source that produces toxic light chains, potentially blocking the disease-driving factors at their root and offering a new treatment option for patients with AL amyloidosis.

Biogen's Autoimmune Therapy Receives FDA Breakthrough Therapy Designation

Biogen announced today that the U.S. FDA has granted Breakthrough Therapy Designation to its investigational antibody litifilimab (BIIB059) for the treatment of cutaneous lupus erythematosus (CLE), a chronic autoimmune disease that primarily affects the skin and currently lacks approved targeted therapies. This Breakthrough Therapy Designation is mainly based on the overall clinical data of litifilimab, including the results of the Phase 2 LILAC study, which were previously published in The New England Journal of Medicine. The data shows,Compared with placebo, litifilimab reduced skin disease activity in CLE patients.The current standard treatment for CLE mainly includes topical steroids, antimalarials, and immunosuppressants. While these therapies help manage symptoms, they are unable to alter the disease course.

Litifilimab is a potential “first-in-class,” humanized IgG1 monoclonal antibody targeting blood dendritic cell antigen 2 (BDCA2).Its mechanism of action involves binding to BDCA2, primarily expressed on the surface of plasmacytoid dendritic cells (pDCs), thereby reducing the production of various pro-inflammatory mediators by pDCs, including Type I interferons. These molecules are considered to play a significant role in the pathogenesis of systemic and cutaneous lupus erythematosus.

References:

[1] Biogen’s Litifilimab Receives FDA Breakthrough Therapy Designation for Cutaneous Lupus Erythematosus, a Disease With No Targeted Treatment Options. Retrieved January 28, 2026 from https://investors.biogen.com/news-releases/news-release-details/biogens-litifilimab-receives-fda-breakthrough-therapy

[2] Immix Biopharma Receives U.S. FDA Breakthrough Therapy Designation for NXC-201. Retrieved January 28, 2026 from https://www.globenewswire.com/news-release/2026/01/28/3227633/0/en/Immix-Biopharma-Receives-U-S-FDA-Breakthrough-Therapy-Designation-for-NXC-201.html

[3] FDA approves daratumumab and hyaluronidase-fihj with bortezomib, lenalidomide, and dexamethasone for newly diagnosed multiple myeloma. Retrieved January 28, 2026 from https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-daratumumab-and-hyaluronidase-fihj-bortezomib-lenalidomide-and-dexamethasone-newly

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