Amgen's Imdelltra is the first and only T-cell engager therapy approved for extensive-stage small cell lung cancer, an aggressive, stubborn cancer that spreads through the body.
On May 16, the FDA granted Imdelltra an accelerated approval. In a trial with 99 study participants with symptomatic brain metastases, interstitial lung disease or non-infectious pneumonitis, the overall response rate was 40% and the median duration of response was 9.7 months.
More approvals for this indication depends on the "verification and description of clinical benefit in a confirmatory trial," Amgen said in a news release.