Spectrum Pharmaceuticals, a biopharmaceutical company focused on novel and targeted oncology therapies, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for poziotinib for the treatment of non-small cell lung cancer (NSCLC) in previously treated patients with HER2 exon 20 mutations. Spectrum plans to submit a new drug application (NDA) for poziotinib later this year.

“There are currently no approved therapies to treat patients with HER2 exon 20 mutations and we are pleased that the FDA has granted Fast Track designation for poziotinib,” said Joe Turgeon, President and CEO of Spectrum Pharmaceuticals. “Momentum is building to unlock the potential of poziotinib.”

“We are actively preparing the NDA and delighted with this Fast Track designation,” stated Francois Lebel, M.D., Chief Medical Officer of Spectrum Pharmaceuticals. “In addition, last week we presented at the European Society for Medical Oncology Targeted Anticancer Therapies (ESMO TAT) Virtual Congress 2021 that twice-daily dosing (BID) suggests improved anti-tumour activity and reduced toxicity relative to once-daily dosing. We are optimistic about this BID strategy and we will provide a data update at AACR in April.”