US Bridging Study Not Enough as FDA Denies Hutchmed's Pancreatic Cancer Drug
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In a Complete Response Letter, the FDA said that it cannot approve the New Drug Application (NDA) for surufatinib for pancreatic (pNETs) and extra-pancreatic (epNETs) neuroendocrine tumors because of insufficient results in both the two Phase III trials that Hutchmed conducted in China and one bridging study in the U.S.
For the FDA to consider giving its green light, Hutchmed will need to launch a multi-regional clinical trial. The FDA stated the studies conducted are not a sufficient representation of the U.S. population.
Surufatinib is a novel, oral angio-immuno kinase inhibitor that prevents the tyrosine kinase activity linked with vascular endothelial growth factor receptors (VEGFR) and fibroblast growth factor receptor (FGFR), which inhibit angiogenesis, and colony-stimulating factor-1 receptor (CSF-1R), which regulates tumor macrophages. Its dual capability may be considered for potential combination treatments with other immunotherapies.
In November 2019, the drug was granted Orphan Drug Designation for pNETS and received a Fast Track Designation from the FDA in April 2020 for pNETs and epNETs. Hutchison applied for the NDA in June 2021.
The FDA assessed the applicability of the Sanet study in China to U.S. medical practice and concluded that an MRCT is necessary to align the drug's development and use with current national practices. Scheduling and inspection issues related to the ongoing COVID-19 pandemic also contributed to the regulator's decision.
"Although this decision from the FDA is disappointing, we remain confident about the clinical value of surufatinib for NET patients and committed to making surufatinib available to patients globally. Throughout the duration of the U.S. review process, we have been transparent and collaborative with the FDA. There are very few treatments approved and used in these rare diseases, and patients and physicians would benefit from more options to address the unmet medical need," Dr. Weiguo Su, Hutchmed CEO and chief scientific officer, said in a statement.
The FDA's disapproval is not related to any safety issues in using surufatinib. Hutchmed said it is cooperating with the FDA to determine its next steps.
"We look forward to continued engagement with the FDA on developing a plan to bring surufatinib to patients in the U.S.," Su added.
Hutchmed also submitted a Marketing Authorization Application in Europe and is conducting a bridging study in Japan. The company said it is preparing to conduct a multi-regional trial similar to the 14-country study involving nearly 700 patients of another product, fruquintinib, for patients diagnosed with metastatic colorectal cancer. Results of this said study are expected to be available by the second half of 2022.