FDA accepts BLA for fixed-dose combination of Perjeta + Herceptin with hyaluronidase, by subcutaneous injection in combination with I.V. chemotherapy for the treatment of HER2-positive breast cancer. Genentech/Roche
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AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) has been approved in the US 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.
National Institute for Health and Care Excellence (NICE) recommends;Tucatinib with trastuzumab and capecitabine for treating HER2-positive advanced breast cancer after 2 or more anti-HER2 therapies Technology appraisal guidance [TA786]Published: 27 April 2022.
Seagen Inc. announced that a jury in the U.S. District Court for the Eastern District of Texas found that Daiichi Sankyo Co. Ltd. infringed Seagen’s U.S. Patent No. 10,808,039 by selling in the United States its Enhertu product (trastuzumab deruxtecan; DS-8201).