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FDA grants orphan drug, fast track designations to AM0010 for treatment of pancreatic cancer
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The FDA granted orphan drug designation to AM0010 for the treatment of pancreatic cancer.
The agency also granted fast track designation to AM0010 (ARMO BioSciences) in combination with FOLFOX chemotherapy for second-line therapy of patients with advanced metastatic pancreatic cancer.
“AM0010 has been shown to specifically engage the immune system to induce comprehensive T-cell activation and objective tumor responses in cancer patients with advanced malignancies,” Peter Van Vlasselaer, PhD, president and CEO of ARMO BioSciences, said in a company-issued press release. “We have completed interactions with the FDA to initiate a potentially registration-enabling clinical development plan for AM0010. Our team is committed to our urgent goal of developing a new treatment for patients with advanced metastatic pancreatic cancer.”
AM0010 is a pegylated form of recombinant human interleukin-10, which has demonstrated durable antitumor activity and a good safety profile in several oncology indications.
An ongoing phase 1 trial — designed to evaluate AM0010 as a single agent, or in combination with standard-of-care chemotherapy drugs or anti-PD-1 antibodies — includes more than 340 patients with advanced solid malignancies.
A pivotal phase 3 trial that will evaluate AM0010 in combination with FOLFOX as second-line therapy for patients with advanced metastatic pancreatic cancer is scheduled to begin by the end of this year.
The FDA Office of Orphan Products Development grants orphan drug designation to novel drugs and biologics that are intended for the safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the United States. The designation allows manufacturers to qualify for various incentives, including tax credits for qualified clinical trials and — upon regulatory approval — 7 years of market exclusivity.