It was already unlikely that the two companies would get a positive outcome from the Oncologic Drugs Advisory Committee (ODAC), after damning assessments by the FDA reviewer in documents published ahead of yesterday’s decisions, but shares in both firms still slumped after the verdicts emerged.
In a 9 to 4 vote, the panellists concluded that pan HER2 inhibitor poziotinib should not be approved by the FDA for patients with HER2 exon 20 insertion-mutated, non-small cell lung cancer (NSCLC), despite their pressing need for treatment options.Spectrum
