A New Biosimilar for a Breast Cancer Rx

FDA approves Ontruzant (trastuzumab-dttb) to treat breast and stomach cancer

(RxWiki News) Written By Anyssa Garza, PharmD, BCMAS

The US Food and Drug Administration (FDA) has approved the third Herceptin (trastuzumab) biosimilar to treat certain types of cancer.

This new medication is found under the name Ontruzant (trastuzumab-dttb). The FDA approved it to treat HER2-positive breast cancer and HER2-overexpressing stomach cancer.

This new drug is approved to treat the same types of cancer as Herceptin because the FDA determined that Ontruzant is a biosimilar medication to Herceptin.

According to the FDA, a biosimilar is a biological product that is highly similar to a biological product that has already been approved. Medications are approved as biosimilars when they are highly similar to existing medications in terms of purity, effectiveness and safety. The original product is known as a reference product. In this case, the reference product is Herceptin (trastuzumab).

In addition to Ontruzant, there are two other biosimilars to Herceptin. These include Ogivri and Herzuma. As of now, no trastuzumab biosimilars have launched in the United States.

This new biosimilar was first approved in Europe. Trastuzumab-dttb was approved to treat advanced HER2-positive breast cancer and HER2-overexpressing stomach cancer. It was also approved to be given in combination with other medications to treat early breast cancer (HER2).

This new medication is available as an injection to be administered into the vein by a health care provider.

Trastuzumab-dttb holds a boxed warning regarding the following issues: risks to unborn babies if given during pregnancy, heart and lung problems and issues when the medication is injected.

In the US, Ontruzant will be commercialized by Merck.