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FDA grants orphan drug designation to STM 434 for ovarian cancer
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The FDA granted orphan drug designation to STM 434 for the treatment of ovarian cancer, according to a press release from the drug’s manufacturer.
STM 434 (Atara Biotherapeutics) — an activin inhibitor — is currently being investigated in a phase 1 study of ovarian cancer and other solid tumors at Memorial Sloan Kettering Cancer Center.
Ovarian cancer is the fifth leading cause of cancer death among U.S. women. According to the NCI, approximately 22,240 women received a diagnosis of ovarian cancer in 2013; further, the disease accounted for 14,030 deaths.
Despite the widespread use of surgery and cytotoxic chemotherapies to treat the disease, outcomes have remained consistent during the last 40 years. According to SEER estimates, the 5-year OS rate is 44%.
“Ovarian cancer is an aggressive tumor type with a significant unmet need for patients,” Isaac Ciechanover, MD, president and CEO of Atara Biotherapeutics, said in a press release. “The receipt of an orphan drug designation for STM 434 is another important milestone for Atara Bio and the progress of our molecularly targeted programs.”
The FDA’s 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.