Keytruda Subcutaneous Approval Granted by FDA

Breakthrough in Cancer Treatment: Subcutaneous Injection of Keytruda Approved

A significant advancement in cancer treatment has been made with the approval of a subcutaneous (SC) formulation of Keytruda, an immune checkpoint inhibitor. This new administration method allows for a quick and efficient delivery of the drug, marking a major shift in how patients receive their treatment.

Alteogen, a biotechnology company, recently announced that its partner, Merck (MSD), based in the United States, has received approval from the U.S. Food and Drug Administration (FDA) for the subcutaneous version of Keytruda. This development is expected to have a substantial impact on both the pharmaceutical industry and patient care.

If Keytruda Kyrex, as it is known, successfully gains traction in the market, Alteogen anticipates generating annual royalty income exceeding 1 trillion Korean won. The company's proprietary technology plays a crucial role in this achievement. It enables the conversion of intravenous (IV) formulations into subcutaneous injections, which can be administered in just a few minutes. This innovation significantly reduces the time patients spend in hospitals, offering a more convenient option for treatment.

The key to this breakthrough lies in Alteogen’s developed enzyme, Hyaluronidase ALT-B4. This enzyme works by breaking down hyaluronic acid layers in subcutaneous tissue, creating space for rapid drug absorption. As a result, existing IV anticancer drugs can now be delivered through subcutaneous injections, making the process faster and less invasive for patients.

Keytruda Kyrex requires a 1-minute injection once every three weeks or a 2-minute injection once every six weeks. This convenience makes it ideal for administration at smaller clinics and hospitals, rather than requiring patients to visit large medical facilities. This shift could lead to more accessible and efficient cancer treatment options for patients across various regions.

The subcutaneous formulation of Keytruda has secured most of the indications approved for the original IV formulation. It has received approval for 38 different cancer types, including melanoma, non-small cell lung cancer, head and neck cancer, urothelial carcinoma, gastric cancer, cervical cancer, and bile duct cancer. The drug is expected to be available in the U.S. by the end of this month.

Merck anticipates that 30–40% of all Keytruda users will choose the subcutaneous formulation after its U.S. launch. If this transition proceeds as planned, Keytruda SC’s sales could reach between 20 trillion to 30 trillion Korean won annually by 2030. This projection highlights the potential of the new formulation to revolutionize the treatment landscape.

Industry experts believe that Alteogen will benefit significantly from the FDA’s approval of the SC formulation. The company is expected to secure annual royalty income exceeding 1 trillion Korean won, further solidifying its position in the biotechnology sector.

This development represents a major milestone in the field of oncology. The ability to administer cancer treatments quickly and efficiently not only improves patient experience but also enhances the overall healthcare system. As more patients gain access to this innovative treatment, the future of cancer care looks increasingly promising.