Shots:

• The US FDA’s BT designation is based on an ongoing P-II DESTINY-Lung01 study assessing Enhertu in 170 patients with HER2 mutant or HER2 overexpressing unresectable and m-nsq. NSCLC- progressed after one or more systemic therapies including CT- molecular targeted therapy or immunotherapy and data from P-I study- published in Cancer Discovery
• The overall safety and tolerability profile of Enhertu in the ongoing DESTINY-Lung01 study is consistent with the P-I study. This designation marks the third BT designation for Enhertu in the US and the fourth expedited regulatory designation received globally
• Enhertu is a HER2 directed ADC- received accelerated approval in the US & approval in Japan under the conditional early approval system for unresectable/ metastatic HER2 positive metastatic BC- prior treated with anti-HER2 based regimens

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Ref: Businesswire | Image: AstraZenca