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All Oncology News

FDA

The FDA has approved capivasertib plus fulvestrant for the treatment of patients with HR-positive, HER2-negative, locally advanced or metastatic breast cancer harboring 1 or more PIK3CA, AKT1, or PTEN alterations, following progression on at least 1 endocrine-based regimen in the metastatic setting or recurrence on or within 12 months of completing adjuvant therapy.

Nicolas Girard, MD, PhD

With a plethora of data coming out of the 2023 European Society for Medical Oncology Congress, findings from multiple clinical trials examining antibody-drug conjugates in non–small cell lung cancer demonstrated encouraging antitumor activity and manageable safety profiles, including results from the phase 3 TROPION-Lung01 study, which evaluated datopotamab deruxtecan vs docetaxel in pretreated patients with advanced or metastatic disease.

The addition of pembrolizumab (Keytruda) to enzalutamide (Xtandi) and androgen deprivation therapy did not improve radiographic progression-free survival vs placebo plus enzalutamide and ADT in patients with metastatic hormone-sensitive prostate cancer, according to data from the phase 3 KEYNOTE-991 trial presented at the 2023 ESMO Congress.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion supporting the approval of momelotinib for the treatment of disease-related splenomegaly or symptoms in adult patients with moderate to severe anemia with primary myelofibrosis, post–polycythemia vera myelofibrosis, or post–essential thrombocytopenia myelofibrosis who have not been exposed to a JAK inhibitor or who had received prior ruxolitinib.

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After a re-examination procedure, the European Medicines Agency’s Committee for Medicinal Products for Human Use has issued a positive opinion on the conditional marketing authorization application for adagrasib in the treatment of adult patients with KRAS G12C–mutated advanced non–small cell lung cancer whose disease progressed following at least 1 prior systemic treatment.