Halozyme Therapeutics Secures FDA Approval for DARZALEX Faspro® in High-Risk Multiple Myeloma Treatment

Halozyme Therapeutics Gains FDA Approval for Innovative Treatment in Multiple Myeloma

Halozyme Therapeutics, Inc. announces a significant milestone with the FDA approval of DARZALEX Faspro® (daratumumab and hyaluronidase-fihj) for the treatment of high-risk smoldering multiple myeloma (HR-SMM). This groundbreaking approval marks DARZALEX Faspro® as the first-ever treatment specifically indicated for HR-SMM, allowing healthcare providers to administer therapy earlier in the disease course. Dr. Helen Torley, CEO of Halozyme, highlights the importance of this development as it expands the therapeutic landscape for multiple myeloma, reinforcing the role of DARZALEX Faspro® as a fundamental treatment option at all disease stages.

With over 36,000 new multiple myeloma cases expected in the U.S. by 2025, and approximately 15% of those classified as smoldering, the need for effective early intervention is paramount. Current standard care involves active monitoring for signs of disease progression, which has proven inadequate for many patients. Notably, it is estimated that about 50% of patients diagnosed with HR-SMM may progress to active disease within two years. The FDA's approval is based on the results of the AQUILA study (NCT03301220), a comprehensive Phase 3 trial that compared the efficacy and safety of DARZALEX Faspro® against the traditional monitoring approach, providing robust data that supports the new indication.

Halozyme's commitment to improving patient outcomes extends beyond this approval. The company leverages its proprietary ENHANZE® technology, which facilitates subcutaneous drug delivery, enhancing the overall treatment experience for patients. With its technology already in use for over one million patients across ten commercialized products in more than 100 markets globally, Halozyme is poised to further advance its drug delivery solutions. The company continues to collaborate with leading pharmaceutical partners, including Roche and Takeda, to innovate and expand the applications of ENHANZE® technology.

In summary, the FDA's approval of DARZALEX Faspro® for HR-SMM signifies a pivotal advancement in the treatment of multiple myeloma, offering hope for early intervention and improved patient outcomes. Halozyme Therapeutics remains at the forefront of oncology innovation, dedicated to enhancing therapeutic options for patients while solidifying its position in the biopharmaceutical landscape.