Enhertu has now been granted five Breakthrough Therapy Designations, including three in breast cancer and one in both lung and gastric cancers
The facility will manufacture its Herceptin biosimilar, Tuznue
Enhertu is a HER2-directed antibody drug conjugate (ADC) being jointly developed by AstraZeneca and Daiichi Sankyo.
Trastuzumab is monoclonal antibody used to treat human epidermal growth factor receptor 2 positive (HER2+) breast cancer and metastatic gastric cancers
Innovative market development collaboration also signed, expanding the availability of select Novartis oncology products in regions across China currently not covered by Novartis
The NMPA approval is based on the positive data of GEMSTONE-302 study, a multi-center, randomized, double-blind, phase III study that evaluated the efficacy and safety of Cejemly or placebo in combination with chemotherapy in first-line stage IV NSCLC patients
The license agreement grants Dr. Reddy's the exclusive rights to commercialize the proposed biosimilar in select countries in Latin America and Southeast Asia
It is used for the treatment of advanced colorectal and gastric cancer
The recommendation is based on positive results from the pivotal Phase 3 CheckMate -649 trial in which Opdivo plus chemotherapy demonstrated superior overall survival versus chemotherapy
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