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All Oncology News

The FDA has approved pembrolizumab for the treatment of patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express PD-L1 (combined positive score ≥10) as determined by an FDA-approved test, with disease progression after ≥1 prior lines of systemic therapy.

Pembrolizumab in combination with chemotherapy led to a statistically significant improvement in pathological complete response rates compared with placebo plus chemotherapy in the neoadjuvant phase of a neoadjuvant/adjuvant treatment regimen in patients with triple-negative breast cancer, meeting one of the dual primary endpoints of the phase III KEYNOTE-522 trial.

The European Medicines Agency's Committee for Medicinal Products for Human Use has recommended approving elotuzumab (Empliciti) for use in combination with pomalidomide (Pomalyst) and low-dose dexamethasone for the treatment of patients with relapsed/refractory multiple myeloma following 2 or more prior therapies, including lenalidomide (Revlimid) and a proteasome inhibitor.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended approval of larotrectinib for the treatment of adult and pediatric patients with solid tumors that have an NTRK gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have no satisfactory alternative treatments or that have progressed following treatment.

The European Medicines Agency's Committee for Medicinal Products for Human Use has backed approval of TAS-102 for the treatment of adult patients with metastatic gastric cancer, including adenocarcinoma of the gastroesophageal junction, following treatment with at least 2 prior systemic regimens for advanced disease.

The combination of nivolumab (Opdivo) and low-dose ipilimumab (Yervoy) was superior in overall survival compared with chemotherapy for the first-line treatment of patients with non–small cell lung cancer whose tumors express PD-L1 ≥1%, meeting the co-primary endpoint of part 1a of the phase III CheckMate-227 trial.