In the DESTINY-PanTumor02 trial, subjects treated with Daiichi Sankyo-AstraZeneca’s Enhertu achieved a confirmed ORR of 51.4%. Credit: Anna in Sweden / Shutterstock.com.
Navigating post-approval research and reimbursement for orphan therapies
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Source: Pharmaceutical Technology
The approval hinges on the observed objective response rate (ORR) and duration of response (DOR) reported in these trials. Continued approval will depend on further verification and clinical benefit demonstrated in confirmatory trials.
In the DESTINY-PanTumor02 trial, subjects treated with Enhertu achieved a confirmed ORR of 51.4% and a median DoR of 19.4 months.
The DESTINY-Lung01 trial enrolled HER2-positive (IHC 3+) non-small cell lung cancer patients and reported a confirmed ORR of 52.9%. The DESTINY-CRC02 trial, which included patients with colorectal cancer, showed a confirmed ORR of 46.9% and a median DOR of 5.5 months.
“This approval also elevates the importance of testing for biomarkers, including HER2, across a broad range of tumours to ensure these patients with advanced cancer who have few options know whether a targeted medicine might be right for them.”
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