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FDA grants orphan drug status to pritumumab for brain cancer
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The FDA has granted orphan drug designation to pritumumab for the treatment of brain cancer, according to a press release from the drug’s manufacturer.
According to the manufacturer’s website, pritumumab (Nascent Biotech) is a natural human IgG antibody derived from a B cell isolated from a tumor-draining lymph node of a patient with cervical cancer.
In multiple phase 2 trials conducted in Japan, patients with brain cancer treated with pritumumab had an overall response rate of 25% to 30%, with several survivors living beyond 5 years after therapy. Toxicities were minimal, confirming the safety of the agent, the website said.
“Our data are comparable with the data generated in the earlier Japanese studies,” Mark Glassy, MD, chief science officer at Nascent Biotech, said in the release. “We anticipate that by modifying the dosing of the previous Japanese human clinical trials, during upcoming domestic human clinical trials, we have the potential to markedly improve response rates.”
To receive orphan drug designation from the FDA’s Office of Orphan Products Development, a novel agent has to treat a rare disease — one that affects fewer than 200,000 patients per year.
Orphan drugs also are allowed to be tested on a smaller cohort of patients, and once commercialized, the manufacturer has 7 years of exclusive rights to market its product before a similar agent can be marketed by another manufacturer.