While several months behind in terms of potential approval, Mirati Therapeutics, Inc. is gearing up to present some tough competition for Amgen, Inc. in the KRAS G12C inhibitor space as it looks forward to a regulatory filing for adagrasib later in the year. A breakthrough therapy designation from the US Food and Drug Administration adds further weight to Mirati’s case, although the company continues to face concerns about adagrasib’s safety profile as a potential disadvantage relative to Amgen’s recently approved Lumakras (sotorasib).
San Diego-based Mirati announced the breakthrough therapy designation (BTD) for adagrasib on 24 June, covering potential use for non-small cell lung cancer (NSCLC) patients who harbor KRAS G12C mutations, following prior systemic therapy