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All Oncology News

The FDA has approved ABP 980 (Kanjinti; trastuzumab-anns), a trastuzumab biosimilar, for the treatment of patients with HER2-overexpressing breast cancer as well as HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma, marking the fifth approval by the agency for a trastuzumab biosimilar.

The FDA has approved pembrolizumab (Keytruda) for the first-line treatment of patients with metastatic or unresectable recurrent head and neck squamous cell carcinoma as monotherapy whose tumors express PD-L1 (composite positive score [CPS] ≥1) and also in combination with platinum and fluorouracil (FU) for this patient population, irrespective of PD-L1 expression.

The combination of acalabrutinib (Calquence) and obinutuzumab (Gazyva) demonstrated a statistically significant and clinically meaningful improvement in progression-free survival compared with obinutuzumab/chlorambucil in patients with previously untreated chronic lymphocytic leukemia, meeting the primary endpoint of the phase III ELEVATE-TN trial.

Ixazomib in combination with dexamethasone did not demonstrate a significant improvement in overall hematologic response compared with standard therapy in patients with relapsed/refractory systemic light-chain amyloidosis, missing one of two primary endpoints in the phase III TOURMALINE-AL1 trial and leading to discontinuation of the study.

The FDA has accepted a biologics license application for the investigational erythroid maturation agent luspatercept for the treatment of adult patients with very low- to intermediate-risk myelodysplastic syndromes-associated anemia who have ring sideroblasts and require red blood cell (RBC) transfusions, as well as for adult patients with beta-thalassemia-associated anemia who require RBC transfusions.