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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.