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Home » AstraZeneca and Daiichi Sankyo HER2 Drug Enhertu Gains Priority Review for NSCLC
AstraZeneca and Daiichi Sankyo HER2 Drug Enhertu Gains Priority Review for NSCLC
April 20, 2022
The FDA has granted a priority review to AstraZeneca’s and Daiichi Sankyo’s cancer drug Enhertu (trastuzumab deruxtecan) for the treatment of adult patients with unresectable or metastatic nonsmall-cell lung cancer (NSCLC).
The companies supported the sBLA filing with positive results from a phase 2 study in 91 participants. More than half of those treated showed an improvement and the disease control rate — which measures the sum of the complete, partial and stable disease rates — was 92.3 percent.
The FDA first approved Enhertu in 2019 for patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma. The potential blockbuster drug has also received accelerated approval for treatment of unresectable or metastatic HER2-positive breast cancer.
The priority review ;designation means the FDA aims to issue a decision on the application within six months instead of the standard 10 months.
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