The company said poziotinib did not get the designation for the treatment of patients with metastatic non-small cell lung cancer (NSCLC).
According to the FDA, breakthrough therapy designation is for a drug that treats a serious or life-threatening condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement on a clinically significant endpoint/s over available therapies.
Breakthrough therapy designation can lead to fast-track approval of a drug by the FDA.
Shares of Spectrum Pharmaceuticals fell by a third of its value, sinking 33.7% to $6.92 in the premarket on Thursday. On Wednesday, the shares ended 1.5% lower at $10.44.
“Our enthusiasm for poziotinib, our commitment to the program, and our overall development plan remain unchanged,” said Joe Turgeon, President and CEO of Spectrum Pharmaceuticals, adding they will "work with the FDA to achieve the fastest route to approval of poziotinib."
Spectrum received exclusive license from Hanmi Pharmaceuticals to develop, manufacture, and commercialize poziotinib worldwide, excluding Korea and China.
Poziotinib is currently being investigated by Spectrum and Hanmi in several mid-stage trials in multiple solid tumors.
Spectrum Pharmaceuticals develops and commercializes oncology and hematology drug products. The company is based in Henderson, Nevada.
Contact Rene Pastor by [email protected]