Advancements in endometrial treatment - Hutchmed & Innovent's cancer combo NDA accepted with Priority Review

By Liza Laws

- Last updated on GMT

© Getty Images
© Getty Images

Related tags endometrial cancer NDA Food and drug administration Fda gynecological

In an important announcement today (April 2), Hutchmed and Innovent jointly revealed the acceptance of their New Drug Application (NDA) in China for the combination of Fruquintinib with Sintilimab.

The drug is intended for the treatment of advanced endometrial cancer and the news carries significant weight as it comes with Priority Review status, underscoring the potential impact of this therapeutic approach in addressing a critical medical need.

“This is the first regulatory filing for the combination of fruquintinib and the immune checkpoint inhibitor sintilimab. It also represents an important step closer to reshaping the treatment landscape for this challenging disease in China,” said Dr Michael Shi, head of R&D and chief medical officer of Hutchmed.

“Endometrial cancer remains one of the most common gynecological malignancies. We look forward to bringing this much-awaited treatment advancement to endometrial cancer patients to improve their treatment outcome.”

Cancer begins in the uterus

This cancer is a type that begins in the uterus. According to The Global Cancer Observatory, an estimated 417,000 people were diagnosed with endometrial cancer, and it caused approximately 97,000 deaths in 2020. In China, an estimated 82,000 people were diagnosed with endometrial cancer, causing approximately 17,000 deaths in 2020. Although early-stage endometrial cancer can be surgically resected, recurrent and/or metastatic endometrial cancer remains an area of high unmet need with poor outcomes and limited treatment options.

The collaboration between Hutchmed and Innovent signifies a concerted effort to harness the synergistic potential of Fruquintinib, a highly selective inhibitor of vascular endothelial growth factor receptor (VEGFR), and Sintilimab, an anti-PD-1 monoclonal antibody. This combination therapy represents a novel approach in the treatment landscape for advanced endometrial cancer, aiming to address the limitations of current treatment options and improve patient outcomes.

“TYVYT (sintilimab injection), as a backbone therapy in immuno-oncology, in combination with an anti-angiogenetic drug, may improve the prognosis for endometrial cancer patients in China,” said Dr. Hui Zhou, senior vice president of Innovent.

New treatment option - endometrial cancer patients

“We are excited about the NDA acceptance and priority review designation, which increases our potential to bring a new treatment option to endometrial cancer patients, and concurrently strengthens the leadership position of TYVYT in China.”

The Priority Review designation granted to the NDA underscores the regulatory recognition of the urgent medical need for effective therapies in advanced endometrial cancer. It also reflects the promising clinical data supporting the safety and efficacy of the Fruquintinib-Sintilimab combination, which has demonstrated encouraging results in clinical trials.

The acceptance of the NDA marks a pivotal moment in the journey towards providing patients with advanced endometrial cancer access to a promising new treatment option. Both Hutchmed and Innovent remain committed to advancing the development and regulatory review process, with the ultimate goal of improving outcomes and quality of life for patients battling this devastating disease.

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