Daiichi Sankyo and AstraZeneca’s Enhertu (fam-trastuzumab deruxtecan-nxki) Receive the US FDA’s Breakthrough Therapy Designation for HER2 Mutant Metastatic Non-Small Cell Lung Cancer

 Daiichi Sankyo and AstraZeneca’s Enhertu (fam-trastuzumab deruxtecan-nxki) Receive the US FDA’s Breakthrough Therapy Designation for HER2 Mutant Metastatic Non-Small Cell Lung Cancer

Daiichi and AstraZeneca’s Enhertu (fam-trastuzumab deruxtecan-nxki) Receives the US FDA’s Breakthrough Therapy Designation for HER2 Mutant Metastatic Non-Small Cell Lung Cancer

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

Click here ­to­ read full press release/ article | Ref: Businesswire | Image: Youtube

Related News: AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) Receive the FDA’s Accelerated Approval for HER-2 Positive Unresectable/ Metastatic Breast Cancer

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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