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.
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