EU Approves Datroway for First-Line Metastatic TNBC; FDA Broadens Pluvicto’s Reach with Approval in PSMA+ mHSPC; AbbVie Announces EU Authorization of RINVOQ for Severe Alopecia Areata; Novo Nordisk Announces Latest Developments from the ZEUS Phase III Trial; Replimune Secures Positive FDA Advisory Committee Vote for RP1 in Advanced Melanoma

Datroway Receives EU Approval for First-Line Metastatic TNBC Patients Ineligible for Immunotherapy

AstraZeneca and Daiichi Sankyo have secured European Commission approval for Datroway (datopotamab deruxtecan) as a monotherapy for the first-line treatment of adults with unresectable or metastatic triple-negative breast cancer (TNBC) who are not eligible for PD-1/PD-L1 inhibitor therapy.

The authorization follows a favorable recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) and is supported by findings from the Phase III TROPION-Breast02 study. The trial results were unveiled at the 2025 European Society for Medical Oncology (ESMO) Congress and later published in Annals of Oncology.

Commenting on the approval, Giuseppe Curigliano, MD, PhD, Director of the Early Drug Development Division at the European Institute of Oncology and Professor of Medical Oncology at the University of Milan, emphasized the need for additional treatment options for patients with metastatic TNBC. He noted that while therapeutic progress has been made, the majority of patients remain ineligible for immunotherapy and have historically relied on chemotherapy. He added that the approval of datopotamab deruxtecan represents an important advancement, offering a meaningful new option for eligible patients facing this aggressive disease.

Dave Fredrickson, Executive Vice President of AstraZeneca’s Oncology Haematology Business Unit, highlighted that more than 80,000 people in Europe are diagnosed with TNBC each year, with the disease disproportionately affecting younger women and presenting limited treatment options in the metastatic setting. He said the approval introduces an antibody-drug conjugate with a differentiated clinical profile and a demonstrated overall survival benefit for patients in need of more effective therapies.

Ken Keller, Global Head of Oncology Business and President and CEO of Daiichi Sankyo, Inc., stated that Datroway is the first and only TROP2-directed antibody-drug conjugate approved in the European Union to demonstrate an overall survival benefit in the first-line treatment of metastatic TNBC. He added that the approval reinforces the company’s commitment to delivering innovative cancer therapies that address significant unmet medical needs while offering patients the potential for extended survival.

The Phase III TROPION-Breast02 trial enrolled patients with metastatic TNBC who experienced an early relapse following previous treatment. Compared with standard chemotherapy, Datroway achieved a statistically significant and clinically meaningful improvement in median overall survival of five months, extending median OS to 23.7 months versus 18.7 months with chemotherapy (HR 0.79; 95% CI: 0.64–0.98; p=0.0291). The therapy also reduced the risk of disease progression or death by 43% (HR 0.57; 95% CI: 0.47–0.69; p<0.0001) based on blinded independent central review and delivered a substantially higher objective response rate of 62.5%, compared with 29.3% for chemotherapy.

The safety findings observed in TROPION-Breast02 were consistent with the established safety profile reported in previous Datroway breast cancer studies. The compelling clinical evidence from TROPION-Breast02 has led to Datroway’s inclusion in the ESMO Clinical Practice Guidelines as a Category IA first-line treatment option for metastatic TNBC patients who are not suitable candidates for immunotherapy. The guidelines also identify Datroway as the preferred treatment for patients whose disease recurs within six months of completing adjuvant therapy. Additionally, the therapy received a score of 4 out of 5 on the ESMO Magnitude of Clinical Benefit Scale (ESMO-MCBS), reflecting its meaningful clinical benefit.

Earlier, in May 2026, Datroway received U.S. approval for the same indication. Regulatory reviews are also ongoing in China, Japan, Australia, Canada, Singapore, and Switzerland through Project Orbis. Datroway is a TROP2-targeted DXd antibody-drug conjugate originally discovered by Daiichi Sankyo and is being co-developed and commercialized worldwide in partnership with AstraZeneca.

FDA Approves Pluvicto for PSMA+ mHSPC, Bringing Radioligand Therapy Earlier in the Disease Course

Novartis announced that the FDA has approved Pluvicto® (lutetium Lu 177 vipivotide tetraxetan) for use in combination with an androgen receptor pathway inhibitor (ARPI) to treat patients with prostate-specific membrane antigen (PSMA)-positive metastatic androgen pathway modulation-naive/sensitive (mAPMN/S) prostate cancer, also referred to as metastatic hormone-sensitive prostate cancer (mHSPC).

The approval was supported by findings from the Phase III PSMAddition trial, where Pluvicto combined with standard of care (ARPI plus androgen deprivation therapy [ADT]) lowered the risk of disease progression or death by 28% (HR 0.72; 95% CI: 0.58–0.90) compared with standard treatment alone. An updated analysis further demonstrated a 33% reduction in the risk of progression or death (HR 0.67; 95% CI: 0.55–0.82), while overall survival data continued to trend in favor of the Pluvicto regimen (HR 0.80; 95% CI: 0.63–1.01) as the study approaches its final survival assessment.

Commenting on the approval, Michael Morris, MD, Prostate Cancer Section Head, GU Oncology at Memorial Sloan Kettering Cancer Center and a principal investigator in the US study, noted that the evolving mHSPC treatment landscape increasingly emphasizes the importance of earlier therapeutic intensification. He added that introducing radioligand therapy at this stage significantly broadens treatment options for clinicians and represents an important advancement for patients.

With this expanded indication, Pluvicto is now approved for use across the full spectrum of PSMA-positive metastatic prostate cancer, nearly doubling the number of patients eligible for treatment. The latest approval extends its established role in metastatic androgen pathway modulation-resistant (mAPMR) or metastatic castration-resistant prostate cancer (mCRPC).

Globally, more than 186,000 men are diagnosed with mHSPC each year. Although treatment outcomes have improved, approximately one-third of patients fail to achieve undetectable prostate-specific antigen (PSA) levels with ARPI-ADT doublet therapy, and nearly half progress to castration-resistant disease within 20 months. These findings underscore the value of introducing more intensive treatment strategies earlier in the disease course. Additionally, the PSMA biomarker is expressed in over 80% of prostate cancer patients, supporting the broad applicability of PSMA-targeted therapies.

According to Gina Carithers, CEO and President of the Prostate Cancer Foundation, the FDA approval marks a significant shift toward precision medicine and earlier targeted intervention in metastatic prostate cancer. She highlighted that the milestone provides patients with a precision treatment option from the time of metastatic diagnosis, potentially reshaping the standard of care.

The safety and tolerability profile of Pluvicto remained consistent with previous studies, including PSMAfore and VISION. At the primary analysis, grade 3 or higher adverse events occurred in 50.7% of patients receiving Pluvicto plus standard of care versus 43.0% of those treated with standard therapy alone. The most frequently reported adverse events of any grade included dry mouth, fatigue, nausea, hot flushes, and anemia. Longitudinal assessments also showed that health-related quality of life was maintained, with comparable patient-reported outcomes observed between the treatment groups throughout the study.

AbbVie Announces European Commission Approval of RINVOQ for the Treatment of Adults and Adolescents with Severe Alopecia Areata

AbbVie announced that the European Commission (EC) has granted approval for RINVOQ® (upadacitinib; 15 mg and 30 mg, once daily) to treat adults and adolescents aged 12 years and older with severe alopecia areata (AA) across the European Union. The approval is based on findings from the ongoing Phase III UP-AA clinical program (M23-716), which consists of two replicate, randomized, double-blind, placebo-controlled studies assessing the efficacy and safety of RINVOQ in patients with severe AA.

Results from both studies demonstrated that the 15 mg and 30 mg doses achieved the primary endpoint at Week 24, with significantly more patients reaching a Severity of Alopecia Tool (SALT) score of 20 or less, corresponding to at least 80% scalp hair coverage, compared with placebo. Both dose groups also met key secondary endpoints, including complete scalp hair regrowth (SALT score of 0) by Week 24. The safety profile observed during the studies was consistent with the established safety profile of RINVOQ across its approved indications.

Commenting on the approval, Roopal Thakkar, M.D., Executive Vice President, Research and Development and Chief Scientific Officer at AbbVie, stated that the EC decision introduces an important new treatment option for individuals living with severe alopecia areata in the European Union. He noted that RINVOQ demonstrated meaningful scalp hair regrowth, including complete regrowth in some patients, offering a valuable option for managing a disease that often carries significant physical and emotional challenges.

Alopecia areata is a chronic autoimmune disorder characterized by unpredictable hair loss ranging from localized bald patches to complete loss of scalp and body hair. Although the condition is driven by immune dysfunction, it is frequently perceived as a cosmetic issue despite its considerable physical, psychological, social, and economic impact. Research has shown that individuals with alopecia areata are at a substantially increased risk of developing depression and anxiety, with women experiencing an even greater risk. Beyond severe alopecia areata, RINVOQ is approved in the European Union for several immune-mediated conditions, including atopic dermatitis, non-segmental vitiligo, rheumatoid arthritis, psoriatic arthritis, radiographic and non-radiographic axial spondyloarthritis, ulcerative colitis, Crohn’s disease, and giant cell arteritis.

Novo Nordisk Shares Update on ZEUS Phase III Trial in People with ASCVD, CKD, and Inflammation

Novo Nordisk announced topline findings from the Phase III ZEUS cardiovascular outcomes trial evaluating ziltivekimab in patients with atherosclerotic cardiovascular disease (ASCVD), chronic kidney disease (CKD), and inflammation. Although the investigational therapy successfully engaged its target and inhibited the IL-6 pathway, demonstrated by anticipated reductions in free IL-6 and high-sensitivity C-reactive protein (hsCRP), it failed to reduce the risk of major adverse cardiovascular events (MACE) compared with placebo (hazard ratio: 0.99; 95% CI: 0.88–1.11). 

The double-blind, placebo-controlled study enrolled more than 6,300 participants and assessed the efficacy of once-monthly ziltivekimab 15 mg in preventing cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke. According to Novo Nordisk, while the trial confirmed the biological activity of IL-6 inhibition, it did not demonstrate the expected clinical benefit in reducing cardiovascular events. The safety profile was generally consistent with placebo, although serious infections occurred more frequently among patients receiving ziltivekimab, in line with IL-6 pathway inhibition. 

No difference in all-cause mortality was observed between treatment groups. Despite the outcome, Novo Nordisk reaffirmed its commitment to cardiovascular research, with the ongoing Phase III HERMES and ARTEMIS trials evaluating ziltivekimab in heart failure and post-acute myocardial infarction patients expected to report results in the first half of 2027.

Replimune Advances RP1 Following Favorable FDA Advisory Committee Outcome in Advanced Melanoma

Replimune Group, Inc. announced the outcome of the FDA Cellular, Tissue, and Gene Therapies Advisory Committee (CTGTAC) meeting, during which the committee reviewed the resubmitted Biologics License Application (BLA) for RP1 (vusolimogene oderparepvec) in combination with nivolumab for patients with advanced melanoma whose disease has progressed following prior anti-PD-1 therapy.

During the meeting, the advisory committee evaluated two primary issues: whether the design and execution of the single-arm IGNYTE trial provided a reliable assessment of the anticipated response rate and durability of response in the intended patient population, and whether the trial’s reported response rate and duration of response were clinically meaningful and reflected systemic antitumor activity attributable to RP1. Following these discussions, the committee voted 10–3 in favor of the conclusion that the efficacy findings from the IGNYTE study are both evaluable and clinically meaningful.

“We are pleased with today’s outcome and appreciate the committee’s careful evaluation of the IGNYTE study results,” said Sushil Patel, Ph.D., Chief Executive Officer of Replimune. “We also extend our gratitude to the patients and physicians who shared their experiences and highlighted the significant unmet need for effective treatment options in advanced melanoma. This marks an important milestone for patients whose disease has progressed after anti-PD-1 therapy, and we look forward to continuing our collaboration with the FDA as it completes its review of the BLA before the scheduled decision date.”

The FDA is expected to complete its review of the Class 1 BLA resubmission by its target action date of August 2, 2026.