| |DECEMBER 20258ROCHE STRENGTHENS MASS SPEC LEADERSHIP WITH LATEST CE MARK APPROVALPFIZER'S TUKYSA SETS NEW PACE IN HER2-POSITIVE METASTATIC TREATMENTPfizer's HER2-targeted therapy TUKYSA delivered a strong boost in first-line maintenance treatment for HER2-positive metastatic breast cancer, marking a major advance in today's data from the Phase 3 HER2CLIMB-05 trial.The study showed that adding TUKYSA, trastuzumab, and pertuzumab after initial chemotherapy cut the risk of disease progression or death by 35.9% compared with the current maintenance approach.Findings were published in the Journal of Clinical Oncology and presented at the San Antonio Breast Cancer Symposium, giving the industry a closer look at how this regimen could reshape front-line care. Median progression-free survival reached 24.9 months with TUKYSA, up from 16.3 months on placebo, offering patients an 8.6-month gain without disease growth.The benefit held across patient groups, including those with brain metastases, a group often facing limited options. Early overall survival results also leaned in favor of TUKYSA, though the data is still maturing.Erika Hamilton, Principal Investigator of HER2CLIMB-05, noted that, "Most patients with HER2-positive metastatic breast cancer face disease progression within two years of starting first-line treatment." She added that these results show tucatinib can extend the time patients remain stable while keeping side effects manageable.The safety profile aligned with known effects of the individual drugs, aside from higher but reversible Grade 3 liver enzyme elevations. Common reactions included diarrhea, liver events, and nausea.Jeff Legos, Chief Oncology Officer at Pfizer, said TUKYSA has already become a trusted later-line treatment, and the new data supports its potential role in a chemotherapy-free, first-line maintenance strategy. POTOP STORIESRoche has announced fresh momentum in clinical diagnostics with CE Mark approval for its new mass spectrometry reagent pack, a move that strengthens its position in mass spectrometry testing.The approval expands what is now the broadest IVD menu available for any automated mass spectrometry platform, covering 39 of the most commonly tested targets."When patients get results sooner, we increase the likelihood that they will get the right treatment," said Matt Sause, CEO of Roche Diagnostics. "With a comprehensive menu for automated mass spectrometry, we are giving clinicians and laboratories the tools to make faster, more precise diagnoses, reducing the time from sample to result. This approach also allows clinicians to better monitor the effectiveness of drug therapies and to optimise antibiotic use, a vital step in combating the major global healthcare challenge of antimicrobial resistance."The Ionify reagent portfolio for the cobas Mass Spec solution includes tests for therapeutic drug monitoring of immunosuppressants and antibiotics, along with steroid hormones and vitamin D metabolites. By shifting from manual workflows to a fully automated setup, labs gain a standardized and easier way to run complex assays. Roche plans to grow this portfolio, including its first drugs-of-abuse panel and additional therapeutic drug monitoring assays.The cobas Mass Spec solution is available in CE Mark markets, as well as the United States, the United Kingdom, Canada, and Japan. In the U.S., Roche also secured a "moderate complexity" CLIA categorization for its first analyte, marking the first mass spectrometry assay to earn this designation. PO
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