Johnson & Johnson’s Darzalex Achieves 93% Five-Year Survival in High-Risk SMM; Atara’s Off-the-Shelf T-Cell Therapy Tab-cel Granted FDA Priority Review

First of Its Kind! Five-Year Overall Survival Rate Reaches 93%, Johnson & Johnson's Monoclonal Antibody Receives Approval Again

Johnson & Johnson recently announced that the European Commission has approvedCD38-Targeted Monoclonal AntibodyDarzalex (daratumumab) Subcutaneous (SC) formulation as monotherapy for the treatment of adult patients with high-risk smoldering multiple myeloma (SMM).According to the press release, Darzalex is the first approved treatment for high-risk SMM patients.

This approval is primarily based on the results of the Phase 3 AQUILA study, which showed that, under a fixed treatment duration,Compared with active monitoring, the Darzalex subcutaneous formulation significantly reduced the risk of patients progressing to active myeloma or death by 51%., demonstrating significant clinical benefits. The AQUILA study enrolled a total of 390 participants, who were respectively treated with Darzalex monotherapy (n=194) or active monitoring (n=196), with a median follow-up time of 65.2 months. The results showed that the progression-free survival rate at 60 months was 63.1% in the Darzalex group, significantly higher than 40.8% in the control group (HR=0.49, p<0.001);The five-year overall survival rates for the two groups were 93.0% and 86.9%, respectively (HR=0.52).In addition, the overall response rate in the Darzalex group reached 63.4%, significantly higher than the 2.0% in the control group, further validating its potential to delay disease progression.

FDA Grants Priority Review to Breakthrough Off-the-Shelf T-cell Therapy

Atara BiotherapeuticsPierre Fabre PharmaceuticalsToday, it was jointly announced that the U.S. FDA has accepted the Biologics License Application (BLA) for tabelecleucel (tab-cel) as a monotherapy for the treatment of Epstein-Barr virus (EBV)-positive post-transplant lymphoproliferative disease (PTLD).Adults andAged 2 years and abovePediatric patients, these patientsHave received at least one prior treatmentThe FDA has granted this application Priority Review, with a PDUFA date of January 10, 2026. Notably, there are currently no FDA-approved treatments available for this indication.

Tab-cel is an allogeneic, "off-the-shelf" EBV-specific T-cell immunotherapy., aiming to target and eliminate EBV-infected cells. The submission includes pivotal and supportive clinical data covering over 430 patients.The pivotal Phase 3 ALLELE study showed an objective response rate of 48.8% (p<0.0001) in treated patients., showing good safety and consistency with previous study results. Previously, tab-cel has been granted Breakthrough Therapy Designation and Orphan Drug Status by the FDA.

Phase 3 Trial Meets Primary and All Secondary Endpoints! AstraZeneca's Innovative Monoclonal Antibody Shines in Results Announcement

AstraZeneca today announced that its nanobody drug gefurulimab successfully met the primary and all secondary endpoints in the global Phase 3 clinical trial PREVAIL. This study is a randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy of gefurulimab in adult patients with generalized myasthenia gravis (gMG) who are positive for anti-acetylcholine receptor antibodies (AChR Ab+).

Gefurulimab is a once-weekly, self-administered subcutaneous C5 complement inhibitor.The test results showed,Gefurulimab significantly improved patients' daily living functions (MG-ADL) at Week 26, with statistical significance and clinical importance, and notably reduced disease severity compared to placebo.Gefurulimab demonstrated good tolerability in this study, with safety consistent with previous findings of C5 inhibitors in gMG patients, and no new safety risks were identified. The full data will be presented at an upcoming medical conference and submitted to regulatory authorities worldwide.

References:

[1] Gefurulimab dual-binding nanobody demonstrated statistically significant and clinically meaningful improvement in functional activities of daily living in adults with generalised myasthenia gravis in PREVAIL Phase III trial. Retrieved July 24, 2025 from https://www.astrazeneca.com/media-centre/press-releases/2025/gefurulimab-nanobody-met-phase-iii-endpoints.html

[2] European Commission approves DARZALEX® (daratumumab) as the first licensed treatment for patients with high-risk smouldering multiple myeloma. Retrieved July 24, 2025 from https://www.globenewswire.com/news-release/2025/07/23/3120055/0/en/European-Commission-approves-DARZALEX-daratumumab-as-the-first-licensed-treatment-for-patients-with-high-risk-smouldering-multiple-myeloma.html

[3] Atara Biotherapeutics Announces U.S. FDA Acceptance and Priority Review of the Biologics License Application for Tabelecleucel (Tab-cel®) for the Treatment of Epstein-Barr Virus Positive Post-Transplant Lymphoproliferative Disease. Retrieved July 24, 2025 from https://www.businesswire.com/news/home/20250724273588/en/Atara-Biotherapeutics-Announces-U.S.-FDA-Acceptance-and-Priority-Review-of-the-Biologics-License-Application-for-Tabelecleucel-Tab-cel-for-the-Treatment-of-Epstein-Barr-Virus-Positive-Post-Transplant-Lymphoproliferative-Disease