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

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

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

Shots:

  • The accelerated approval is based on P-II DESTINY-Breast01 study assessing Enhertu (5.4mg/kg) as monothx. in 184 patients with HER2-positive mBC, prior treated with two or more anti-HER2 based regimens in the metastatic setting at 100+ sites globally
  • The P-II DESTINY-Breast01 study results: ORR (60.3%); CR (4.3%); PR (56.0%); mDOR (14.8mos. as of Aug 01, 2019); mPFS (16.4mos.)
  • Enhertu is a HER2-directed ADC, currently being evaluated in three ongoing P-III studies for exploring its potential in other indications. The regulatory submission has been made to the MHLW based on DESTINY-Breast01 and P-I studies

Click here ­to­ read full press release/ article | Ref: AstraZeneca | Image: Twitter

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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