Rolling submission with the FDA for surufatinib treatment in patients with pancreatic and extra-pancreatic neoendocrume tumors was completed and an expanded access program for the drug is currently underway for patients in the United States.
Completion of a rolling submission for the new drug application (NDA) for surufatinib in the treatment of pancreatic and extra-pancreatic nonendocrine tumors (NETs) was recently announced by HUTCHMED Limited, the company responsible for developing the agent.1
The submission for FDA approval is based on data from the 2 phase 3 trials in China and 1 study in United States.
“HUTCHMED is developing 6 novel oncology drug candidates internationally and this surufatinib NDA represents our first ever in the United States. Having successfully launched surufatinib in China early this year, we are now looking forward, subject to its approval, to being able to provide access to this important new therapeutic option for NET patients in the U.S. and beyond,” Marek Kania, MD, MBA, Managing Director and Chief Medical Officer of HUTCHMED International Corporation, said in a press release. “Our surufatinib NDA submission to the FDA was completed by our rapidly expanding international team of over 70 personnel based mainly in the US, working side by side with our discovery and development colleagues in China.”
In the randomized, double-blind, placebo-controlled phase 3 SANET-p trial (NCT02589821), surufatinib led to a significant improvement in progression-free survival (PFS) versus placebo in patients with progressive, advanced, well differentiated pancreatic NETs (HR, 0.49; 95% CI, 0.32-0.76; P = .0011). In addition, the treatment was considered to be well tolerated in this group, with 22% of patients experiencing serious treatment-related adverse events versus 7% in the placebo arm.2
For patients with unresectable or metastatic, well-differentiated, extrapancreatic NETs treated on the randomized, double-blind, placebo-controlled phase 3 SANET-ep trial (NCT02588170),
surufatinib resulted in a statistically significant improvement In PFS versus placebo (HR, 0.33; 95% CI, 0.22-0.50; P <.0001). Due to the trial meeting a prespecified criteria for early discontinuation, it was terminated at the interim analysis as recommended by the independent data monitoring committee.3
HUTCHMED initiated an expanded access program (NCT04814732) in the United States to bring surufatinib therapy to patients who neuroendocrine tumors who have no satisfactory alternative treatment option. Once eligibility is confirmed, patients are treated with oral surufatinib at 300 mg once daily until disease progression, unacceptable toxicity, death, withdrawal from the program, or in the event the agent becomes commercially available or production is halted. To be eligible, patients must have histologically or cytologically confirmed, well-differentiated, locally advanced or metastatic NETs; be 12 years of age or above; and have no suitable alternative therapy or clinical trial options.
Surufatinib had previously received fast track designation from the FDA for therapy of pancreatic and extra-pancreatic NETs in 2020 and was granted orphan drug designation for pancreatic NETs in 2019.
The novel angio-immuno kinase inhibitor works by blocking angiogenesis by way of selective inhibition of tyrosine kinase activity associated with VEGFR and FGFR. In addition, regulation of tumor-associated macrophages is disrupted by blocking of the colony stimulating factor-1 receptor, which promotes the body’s immune system to respond to the tumor cells.
1. HUTCHMED completes rolling submission of NDA to U.S. FDA for surufatinib for the treatment of advanced neuroendocrine tumors. News release. HUTCHMED. May 3, 2021. Accessed May 3, 2021. https://bit.ly/2QPI8wi
2. Xu J, Shen L, Zhou Z, et al. Surufatinib in advanced extrapancreatic neuroendocrine tumours (SANET-ep): a randomised, double-blind, placebo-controlled, phase 3 study. Lancet Oncol. 2020;21(11):1489-1499. doi: 10.1016/S1470-2045(20)30496-4
3. Xu J, Shen L, Bai C, et al. Surufatinib in advanced pancreatic neuroendocrine tumours (SANET-p): a randomised, double-blind, placebo-controlled, phase 3 study. Lancet Oncol. 2020;21(11):1500-1512. doi: 10.1016/S1470-2045(20)30493-9