Genentech Announces FDA Approval of Herceptin Hylecta for Subcutaneous Treatment of Early-Stage HER2-Positive Breast Cancer

VCBeat (WeChat ID: vcbeat) has learned that Genentech, a member of the Roche Group, recently announced that its new product, Herceptin Hylecta, has received FDA approval for subcutaneous injection in the treatment of HER2-positive breast cancer.

Breast cancer is the most common type of cancer among women worldwide, with a mortality rate second only to lung cancer. Data indicate that the lifetime risk of being diagnosed with breast cancer for women in the United States is 12.4%, meaning one in every eight women will be diagnosed with the disease. According to projections by the American Cancer Society, more than 420,000 people were expected to die from this disease in 2019.

Patients with early-stage breast cancer typically experience the following symptoms: joint pain, diarrhea, upper respiratory tract infections, rash, nausea, headache, and fever. Traditional intravenous administration requires 30 to 90 minutes to complete drug delivery, whereas Herceptin Hylecta, a subcutaneous injection, takes only 2 to 5 minutes. Clinical study results show that 86% of patients chose subcutaneous injection to save time.

“After more than 20 years of relentless research, the efficacy of Herceptin Hylecta in the treatment of HER2-positive breast cancer is evident,” said Dr. Sandra Horning, Chief Medical Officer and Head of Global Product Development at Roche. “The FDA approval of Herceptin Hylecta provides physicians and patients in the United States with a superior treatment option.”

Genentech, founded in 1976, is the longest-established biotechnology company in the United States and currently the world’s second-largest biotech firm by scale and strength, after Amgen. Headquartered in South San Francisco, California, it became a member of the Roche Group in 2009 and is dedicated to drug research and development in the fields of oncology, immunology, tissue growth and repair, neuroscience, and infectious diseases.

The successful development of Herceptin Hylecta would not have been possible without Halozyme Therapeutics’ proprietary core technology, Enhanze. This technology utilizes recombinant human hyaluronidase (rHuPH20) to degrade a class of polysaccharides known as hyaluronan. The temporary and reversible degradation of these polysaccharides enhances the diffusion and absorption of macromolecules, thereby facilitating the transition of drug administration from intravenous infusion to subcutaneous injection. The Enhanze drug delivery technology not only shortens the administration time for Herceptin Hylecta but also reduces medication costs for patients.

Halozyme Therapeutics is a biotechnology company headquartered in California, USA, focused on the research and development of novel oncology therapies. In addition to its current collaboration with Roche, the company leverages its proprietary drug delivery technology, Enhanze, to partner with multiple leading global pharmaceutical companies, including Pfizer, Bristol Myers Squibb, and Alexion Pharmaceuticals.

Helen Torley, CEO of Halozyme Therapeutics, stated, “Herceptin Hylecta is the third drug we have developed using Enhanze technology. This FDA approval marks another breakthrough for our company in cancer therapies.”

(Compiled by: Feng Yutong)