logo
  

FDA Oks AstraZeneca's Enhertu To Treat Unresectable Or Metastatic HER2 Positive Breast Cancer

The U.S. Food and Drug Administration approved Daiichi Sankyo and AstraZeneca's (AZN,AZN.L) Enhertu or fam-trastuzumab deruxtecan-nxki for the treatment of adult patients with unresectable or metastatic HER2 positive breast cancer who have received a prior anti-HER2-based regimen either in the metastatic setting, or in the neoadjuvant or adjuvant setting and have developed disease recurrence during or within six months of completing therapy.

Enhertu is a specifically engineered HER2 directed antibody drug conjugate being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca.

The approval by the U.S. Food and Drug Administration was based on positive results from the pivotal DESTINY-Breast03 phase 3 trial that showed ENHERTU reduced the risk of disease progression or death by 72% versus trastuzumab emtansine in patients with HER2 positive unresectable and/or metastatic breast cancer previously treated with trastuzumab and a taxane.

Enhertu is approved with Boxed WARNINGS for interstitial lung disease (ILD)/pneumonitis and Embryo-Fetal toxicity.

For comments and feedback contact: editorial@rttnews.com

Business News

Editors Pick
Healthcare major Johnson & Johnson, which is in the middle of a talcum powder fiasco, said it is discontinuing talc-based JOHNSON'S Baby Powder globally in 2023. The company plans to transition to an all cornstarch-based baby powder portfolio. According to the company, the commercial decision to use cornstarch in all its baby powder products was made after conducting an assessment of its portfolio Walt Disney's streaming service Disney+ is rolling out its much-anticipated new ad-supported subscription plan for Disney+ in the U.S. as part of its bid to stem the loss and make its streaming business profitable after the services posted a hefty operating loss of more than $1 billion in the third quarter. It is also raising pricing for its bundled subscription plans with Hulu, ESPN+ and live TV. The U.S. Food and Drug Administration announced the intended availability of base powder to make around 6 million bottles of specialty formula from Mexico as part of its efforts to meet the nationwide supply shortage caused by Abbott Nutrition recall. Reckitt Nutrition/Mead Johnson Nutrition will send an initial shipment of 331 thousand pounds of base powder for PurAmino Hypoallergenic Formula.
Follow RTT