Trastuzumab-Dttb Approved for Several Cancers

Herceptin Biosimilar Indicated for HER2-Overexpressing Breast Cancer, Metastatic Breast Cancer, and Metastatic Gastric Cancer

The FDA has approved trastuzumab-dttb (Ontruzant, Samsung Bioepis Co., Ltd.) for treatment of HER2-overexpressing breast cancer, metastatic breast cancer, and metastatic gastric cancer or gastroesophageal junction adenocarcinoma in patients not previously treated for metastatic disease.

Trastuzumab-dttb is indicated for adjuvant treatment of HER2-overexpressing node-positive/node-negative breast cancer as part of a regimen containing doxorubicin, cyclophosphamide, and paclitaxel or docetaxel; with docetaxel and carboplatin; and as a single agent following multi-modality anthracycline-based therapy.

The drug is also indicated in combination with paclitaxel for first-line treatment of HER2-overexpressing metastatic breast cancer; as a single agent for this cancer in patients who have had one or more chemotherapy regimens for metastatic disease; in combination with cisplatin and capecitabine or 5-fluorouracil for patients with HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma, with no prior treatment for metastatic disease.

Trastuzumab-dttb administration can result in cardiomyopathy, serious and fatal infusion reactions, and pulmonary toxicity.

Exposure to Ontruzant while pregnant can cause oligohydramnios, sometimes complicated by pulmonary hypoplasia, skeletal abnormalities, and neonatal death.

Source: Drugs.com, January 21, 2019