The U.S. Food and Drug Administration (FDA) has granted fast-track designation to QTX-2101, an oral formulation of an approved chemotherapy drug, as a potential treatment for acute promyelocytic leukemia (APL), a form of blood cancer.
The FDA gives this designation to therapies that have the potential to fulfill unmet medical needs in the treatment of serious conditions. The designation gives QTX-2101’s developer, Quetzal Therapeutics, access to perks such as more frequent communication with the FDA during the drug development process.
QTX-2101 is an oral capsule formulation of arsenic trioxide, a chemotherapy drug that has long been used to help treat APL. Like many other types of chemotherapy, arsenic trioxide is usually administered by intravenous infusion (a slow drip into the bloodstream). Patients undergoing treatment must navigate many clinical visits, which can make it hard or impossible to engage in other activities. An oral version of the therapy could make treatment less burdensome for APL patients.
Simplifying the process for patients
“QTX-2101 is an oral capsule formulation of arsenic trioxide developed to address limitations associated with intravenous administration, including the need for frequent clinic visits,” Quetzal said in a company press release. “The potential for QTX-2101 to simplify treatment administration while maintaining precise dosing and stability is under investigation.”
Data from a Phase 1 trial (NCT04996030) enrolling 15 APL patients suggested that QTX-2101 delivers equivalent amounts of active drug into the body as the standard intravenous version of arsenic trioxide. That trial was sponsored by Syros Pharmaceuticals, which had developed QTX-2101 under the name SY-2101.
Quetzal recently began a Phase 3 clinical trial to further evaluate the safety, efficacy, and pharmacological properties of QTX-2101 in people with APL. The company said the Phase 3 study will be conducted at sites worldwide and will compare QTX-2101 against standard-of-care treatment in people newly diagnosed with APL. The Phase 3 study is designed to be pivotal, meaning that if results are positive, Quetzal may use the data as a basis to apply for regulatory approvals.
The post FDA fast tracks oral chemotherapy formulation for APL appeared first on Rare Cancer News.