Loxo Oncology has been granted Breakthrough Therapy Designation by the U.S. Food & Drug Administration for cancer treatment drug LOXO-292.
The medication is a selective rearranged during transfection (RET) inhibitor for the treatment of patients with advanced RET fusion-positive thyroid cancer who require systemic therapy, have progressed following prior treatment and have no acceptable alternative treatment options.
The designation supplements two LOXO-292 Breakthrough Therapy Designations granted in September.
LOXO-292 is an oral and selective investigational new drug in clinical development for the treatment of patients with cancers that harbor abnormalities in an RET.
RET fusions and mutations occur across multiple tumor types with varying frequency; the Stamford company’s drug was designed to inhibit native RET signaling as well as anticipated acquired resistance mechanisms that could otherwise limit the activity of the therapeutic approach.
The FDA’s Breakthrough Therapy Designation is intended to expedite the development and review of a drug candidate that is planned for use to treat a serious or life-threatening disease or condition when preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints.