AstraZeneca drug gets breakthrough status in early lung cancer
LONDON: AstraZeneca said on Monday its immunotherapy drug Imfinzi had been granted "breakthrough" designation by US regulators for treating non-metastatic lung cancer, following the success of the so-called Pacific trial.
The Food and Drug Administration decision paves the way for a speedy regulatory review and confirms the drug's potential in earlier stage disease, despite its initial failure in the key Mystic trial, which targeted the bigger advanced cancer market.