Amgen’s request to gain full approval of Lumakras in non-small cell lung cancer has been rejected by the FDA. The California pharma will now have to conduct an additional confirmatory trial to gain the coveted FDA nod.
Lumakras was granted accelerated approval in May 2021 to treat second line KRAS G12C-mutated NSCLC. The company was asked by the FDA to launch a confirmatory trial and a dose optimization study to gain a full approval.
The therapy faced an advisory committee meeting in October where a panel was asked to consider whether the primary endpoint for the phase 3 CodeBreak 200 trial could be reliably interpreted in Amgen’s study. The committee voted 10-2 against the measure, suggesting that they were unimpressed with Amgen’s trial design.
Despite the negative vote, the agency was not expected to remove Lumakras from the market, but instead request another confirmatory trial. Amgen now says that’s exactly what the FDA has done, with the request to flip the accelerated approval into a full approval rejected with a complete response letter, according to a December 26 news release.
Amgen will have until February 2028 to complete a new study confirming the clinical benefit of Lumakras.
The biopharma also announced Tuesday that the FDA has agreed with the biopharma that a requirement to compare the 960 mg dose with a lower dose has been fulfilled. In October, Amgen executives expressed confidence that the 960 mg dose was in fact the optimum dose after phase 3 data showed a greater effect for the higher dose group, compared to 240 mg.
Accelerated approval is granted to therapies that treat serious conditions and fill an unmet medical need based on a surrogate endpoint that predicts clinical benefit. The FDA requires companies to complete a confirmatory trial to prove clinical benefit to gain the full approval.
The agency has recently been heightening scrutiny on the accelerated approval process and asking companies to have confirmatory trials underway at the time the initial approval is granted. Another area of concern for the FDA has been so-called “dangling” accelerated approvals, where a drug receives the advanced ok, but the confirmatory trial is not completed on time as requested.

https://www.prnewswire.com/news-releases/amgen-provides-regulatory-update-on-status-of-lumakras-sotorasib-302022131.html