Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020.
REUTERS/Andrew Kelly/File PhotoSept 22 (Reuters) - Advisers to the U.S Food and Drug Administration on Thursday voted against recommending Spectrum Pharmaceuticals' (SPPI.O) experimental drug for the treatment of patients with a form of non-small cell lung cancer.
The FDA panel voted 9 to 4 against the oral drug, poziotinib, citing marginal efficacy, high level of toxicities, and lack of dose optimization.
Poziotinib is intended to treat non-small cell lung cancer (NSCLC) with a rare genetic mutation that affects 2-4% of total patients with NSCLC.
There is no prior FDA-approved treatment for the rare lung cancer, and the patients suffering from the disease are given treatments similar to those with non-small cell lung cancer without the mutation.