The US Food and Drug Administration (FDA) has granted approval to HutchMed (NASDAQ: HCM) and its partner Takeda (NYSE: TAK, TYO: 4502) for their oral tyrosine kinase inhibitor Fruzaqla (fruquintinib), marking the second approval this year for a China-developed innovative drug. The drug is indicated for adult patients with previously treated metastatic colorectal cancer (CRC), including those who have undergone various chemotherapy and targeted therapies.
Fruquintinib’s Mechanism and Indication
Fruquintinib is a selective inhibitor of vascular endothelial growth factor receptors (VEGFR) 1, 2, and 3, which are crucial in blocking tumor angiogenesis. The FDA’s approval is based on the positive results from the global Phase III multi-regional clinical trial (MRCT) FRESCO-2, conducted across the US, Europe, Japan, and Australia, as well as data from the Phase III FRESCO clinical trial conducted in China. These trials compared fruquintinib plus best supportive care (BSC) with placebo plus BSC in patients with previously treated metastatic CRC, meeting their primary and key secondary endpoints, demonstrating significant improvements in overall survival (OS) and progression-free survival (PFS).
Clinical Trial Outcomes and Tolerability
Both the FRESCO-2 and FRESCO clinical trials showed that fruquintinib was generally well tolerated by patients, with a statistically and clinically meaningful impact on survival rates.
Implications for China’s Biotech Sector
This approval is a significant boost for China’s biotech sector, following closely on the heels of Junshi Biosciences and Coherus Biosciences’ first US approval for a China-discovered programmed death-1 inhibitor. Fruquintinib is now the first and only highly selective inhibitor for the treatment of previously treated metastatic CRC that targets all three VEGF receptor kinases, available to all patients regardless of biomarker status.
Financial Implications for HutchMed
The approval also comes with a financial milestone for HutchMed, which is set to receive a USD 35 million payment, along with royalties on net sales achieved by Takeda. The approval arrived over two weeks ahead of the previously issued PDUFA date of November 30, 2023.- Flcube.com
