HUTCHMED Initiates Rolling Submission Of NDA To FDA For Fruquintinib To Treat Refractory CRC

HUTCHMED (China) Limited (HCM) announced Monday that it has initiated the filing of a rolling submission of a New Drug Application or NDA to the U.S. Food and Drug Administration for fruquintinib to treat refractory metastatic colorectal cancer or CRC.

The company said it plans to complete the NDA submission in the first half of 2023, to be followed by filing of a Marketing Authorization Application to the European Medicines Agency and an NDA to the Japan Pharmaceuticals and Medical Devices Agency.

fruquintinib is a highly selective and potent oral inhibitor of VEGFR-1, -2 and -3, for the treatment of refractory metastatic CRC.

Weiguo Su, Executive Director, Chief Executive Officer and Chief Scientific Officer of HUTCHMED, said, "Our U.S. NDA submission includes the successful multi-regional clinical trial, FRESCO-2, designed in consultation with the FDA, the EMA and the PMDA. The study showed a meaningful survival benefit and anti-tumor effect in patients treated with fruquintinib across patient populations, consistent with the pivotal Phase III FRESCO study supporting approval of fruquintinib for CRC in China."

The FDA in June 2020 had granted Fast Track Designation for the development of fruquintinib to treat metastatic CRC, enabling the company to submit sections of the NDA on a rolling basis.

The company noted that the NDA is supported by the global Phase III multi-regional clinical trial (MRCT) FRESCO-2 study conducted in the U.S., Europe, Japan and Australia. The trial investigated fruquintinib plus best supportive care or BSC vs placebo plus BSC in patients with refractory metastatic CRC.

HUTCHMED retains all commercial rights to fruquintinib outside of China. Fruquintinib is approved in China under the brand name ELUNATE, partnered with Eli Lilly and Co.

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