Pluvicto Moves Into First-Line Metastatic Prostate Cancer, Marking Shift Toward Earlier Radioligand Therapy

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A new regulatory approval is reshaping the treatment landscape for metastatic hormone-sensitive prostate cancer (mHSPC), bringing radioligand therapy into much earlier stages of disease. Pluvicto (lutetium Lu-177 vipivotide tetraxetan aka 177Lu-PSMA-617), a therapy targeting prostate-specific membrane antigen (PSMA), can now be used in combination with standard androgen deprivation therapy and androgen receptor pathway inhibitors in […]

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FDA Abandons Two-Trial Standard: Implications for Drug Development

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The FDA announced on February 18, 2026, that it will no longer require two pivotal clinical trials for new drug approvals, establishing a single-trial approach as the default standard. In a New England Journal of Medicine perspective, FDA leaders argued that the “two-trial dogma”, unchallenged since the 1960s, is obsolete given advances in biology, statistical […]

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European Commission Approves Darolutamide Plus ADT for Metastatic Hormone-Sensitive Prostate Cancer

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The European Commission has granted marketing authorization to darolutamide (Nubeqa) combined with androgen deprivation therapy (ADT) for treating metastatic hormone-sensitive prostate cancer (mHSPC). This approval, following a positive opinion from the European Medicines Agency in June 2025, allows darolutamide plus ADT to be used with or without docetaxel, offering clinicians greater flexibility in tailoring treatment. […]

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