New Form of Herceptin Approved by U.S. FDA for Breast Cancer

Herceptin Hylecta allows administration in 2–5 minutes.

Roche’s Herceptin (trastuzumab) has played an important role in developing a treatment for HER2-positive breast cancer. The monoclonal antibody targets the HER2 receptor, a protein that is present in larger quantities on the exterior surfaces of cancer cells in HER2+ cancers. By binding to HER2, trastuzumab blocks a signaling pathway believed to play a role in tumor growth and survival — it may also cause the immune system to destroy the cancer cells.


Intravenous treatment with Herceptin takes 30–90 minutes. However, now patients in the United States –– along with those in Europe and around the world –– have another option. The U.S. Food and Drug Administration recently approved a form of Herceptin that can be delivered subcutaneously (under the skin) in two to five minutes.


Roche’s ready-to-use Herceptin Hylecta (trastuzumab and hyaluronidase-oysk) will soon be available for subcutaneous injection for the treatment of certain people with HER2+ early breast cancer (node-positive, or node-negative and ER/PR-negative or with one high-risk feature), in combination with chemotherapy for HER2+ metastatic breast cancer, and either in combination with paclitaxel or alone — for those who have received one or more chemotherapy regimens for metastatic disease.


Delivery under the skin is made possible with the use of Halozyme's Enhanze technology, which is based on a proprietary recombinant human hyaluronidase PH20 (rHuPH20 enzyme that temporarily degrades hyaluronan, a glycosaminoglycan (or chain of natural sugars in the body)). Degradation of hyaluronan allows the dispersion and absorption of the trastuzumab drug substance.

The FDA’s approval of Herceptin Hylecta was based on the results of several phase III studies that demonstrated its efficacy and safety, as well as the preference of patients for this version over traditional Herceptin treatment.


Cynthia A. Challener, Ph.D.

Dr. Challener is an established industry editor and technical writing expert in the areas of chemistry and pharmaceuticals. She writes for various corporations and associations, as well as marketing agencies and research organizations, including That’s Nice and Nice Insight.