Novartis' Ianalumab Receives FDA Breakthrough Therapy Designation for Sjögren’s Disease; ImmunityBio Reports Positive Results with Chemotherapy-Free, Off-the-Shelf CAR-NK Therapy

Novartis' Monoclonal Antibody Receives FDA Breakthrough Therapy Designation, Submission of Marketing Application Imminent

Novartis announced today that its investigational drug ianalumab has been granted Breakthrough Therapy Designation by the U.S. FDA for the treatment of Sjögren’s disease (SjD).Ianalumab is a fully human monoclonal antibody that achieves B-cell depletion while inhibiting their activation and survival by blocking the BAFF receptor (BAFF-R). Novartis plans to submit ianalumab's marketing application globally starting from early 2026.According to the press release, if approved smoothly, the drug is expected to become the first targeted treatment option for Sjögren's syndrome.

This Breakthrough Therapy Designation is primarily based on the positive results of ianalumab in two global, multicenter, pivotal Phase 3 clinical trials, NEPTUNUS-1 and NEPTUNUS-2. The studies evaluated the efficacy and safety of ianalumab in patients with Sjögren's syndrome, showing that the drug provided clinically meaningful benefits in improving disease activity and reducing the burden of illness for patients. Meanwhile, ianalumab demonstrated a favorable safety profile in both studies, with the overall incidence of adverse events and serious adverse events comparable to placebo.

No Chemotherapy or Lymph Depletion Required! Positive Results of Off-the-Shelf CAR-NK Therapy Announced

ImmunityBio today announced the latest efficacy and safety data from the ongoing QUILT-106 clinical study. The study is evaluating an off-the-shelf allogeneic CD19 chimeric antigen receptor natural killer cell therapy (CAR-NK), known as CD19 t-haNK (CAR-NK), in combination with rituximab (anti-CD20) for the treatment.WaldenstromThe effect of Waldenstrom non-Hodgkin lymphoma, a rare B-cell malignancy. This CAR-NK therapy has been engineered to express a specific CAR targeting CD19, aiming to achieve high-affinity, targeted NK cell therapeutic effects.

The study results showed that CAR-NK combined with rituximab achieved durable complete remission in patients with prior treatment failure.Some patients who could be evaluated over the long term maintained complete remission at 7-month and 15-month follow-ups after receiving a total of four cycles and eight doses, and they did not receive further treatment thereafter.Notably, according to the press release, this therapy is the first CAR-NK cell treatment regimen that does not require chemotherapy or lymphodepletion. It achieved 100% disease control in the first four subjects and was administered entirely in an outpatient setting.

EU Approves Bicyclic Peptide Therapy for Kidney Disease

Sobi announced today that the European Commission (EC) has approved Aspaveli (pegcetacoplan), jointly developed with Apellis Pharmaceuticals, for use in combination with renin-angiotensin system (RAS) inhibitors to treat C3 glomerulopathy (C3G) or primary immune complex-mediated membranoproliferative glomerulonephritis (IC-MPGN) in patients aged 12 to 17 years and adults; for patients who are intolerant or have contraindications to RAS inhibitors, treatment may be administered without the concomitant use of such drugs.

The approval was mainly based on the positive results of the Phase 3 VALIANT study. The study showed,Pegcetacoplan delivers positive and clinically meaningful benefits across multiple key disease indicators, including a 68% reduction in proteinuria levels, helping maintain stable kidney function, and significantly clearing C3 complement deposits in the kidneys.Further analysis showed that these efficacy outcomes were consistent across different patient subgroups, including C3G and primary IC-MPGN patients, adults and adolescents, as well as patients with primary kidney disease and those with recurrent disease post-renal transplantation, all exhibiting similar benefits.

Pegcetacoplan is a pegylated (PEGylated) bicyclic peptide therapy targeting the C3 complement protein.Bicycle molecules combine the characteristics of antibodies, small molecule drugs, and peptides, with affinity and precise targeting specificity similar to antibodies. At the same time, due to their smaller molecular weight, they are able to quickly and deeply penetrate tissues. In May 2021, pegcetacoplan was approved by the FDA for the treatment of paroxysmal nocturnal hemoglobinuria (PNH), marketed under the brand name Empaveli. In July 2025, pegcetacoplan received FDA approval for expanded indications for the treatment of C3G and primary IC-MPGN, to reduce proteinuria in patients.

References:

[1] Novartis ianalumab receives FDA Breakthrough Therapy designation for Sjögren’s disease. Retrieved January 16, 2026 from https://www.globenewswire.com/news-release/2026/01/16/3220482/0/en/Novartis-ianalumab-receives-FDA-Breakthrough-Therapy-designation-for-Sj%C3%B6gren-s-disease.html

[2] Sobi Receives European Commission Approval for Aspaveli® (pegcetacoplan) for the Treatment of C3G and Primary IC-MPGN. Retrieved January 16, 2026 from https://www.prnewswire.com/news-releases/sobi-receives-european-commission-approval-for-aspaveli-pegcetacoplan-for-the-treatment-of-c3g-and-primary-ic-mpgn-302663349.html

[3] ImmunityBio Announces Durable Complete Response of 15 Months with a Chemotherapy-Free CD19 CAR-NK Cell Therapy in Waldenstrom Lymphoma. Retrieved January 16, 2026 from https://www.businesswire.com/news/home/20260116046721/en/ImmunityBio-Announces-Durable-Complete-Response-of-15-Months-with-a-Chemotherapy-Free-CD19-CAR-NK-Cell-Therapy-in-Waldenstrom-Lymphoma

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