Enhertu Secures US BTD Status in Early HER2-Positive Breast Cancer
The US FDA has granted Breakthrough Therapy Designation to Enhertu for use as post-neoadjuvant treatment in patients with HER2-positive early breast cancer, marking the tenth such designation for AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate, supported by phase III DESTINY-Breast05 trial results.
HER2-positive Breast Cancer | 23/12/2025 | By News Bureau
Sandoz and EirGenix Ink Global Licensing Deal for Pertuzumab Biosimilar
Sandoz, the global leader in affordable medicines, has signed a global license agreement with Taiwanese biotech company EirGenix to commercialise a proposed biosimilar of the oncology medicine pertuzumab. The milestone-based deal, valued at up to USD 152 million, includes an upfront payment and potential market-based incentives.
HER2-positive Breast Cancer | 13/11/2025 | By Dineshwori | 275
Daiichi Sankyo Files sNDA in Japan for ENHERTU Plus Pertuzumab in HER2-Positive Breast Cancer
Daiichi Sankyo has filed a supplemental NDA in Japan for ENHERTU plus Pertuzumab in HER2-positive breast cancer. If approved, this therapy could enter the first-line metastatic setting and has the potential to become a new standard of care.
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HER2-Positive Breast Cancer | 08/10/2025 | By Dineshwori | 479
Alkem Launches Pertuzumab Biosimilar Pertuza in India for HER2-Positive Breast Cancer
Alkem Laboratories has introduced Pertuza, a biosimilar of pertuzumab, in India for the treatment of HER2-positive breast cancer. The drug is supplied as a 420 mg/14 mL injection and is developed and manufactured domestically.
HER2-Positive Breast Cancer | 23/09/2025 | By Darshana | 309
CuraTeQ Biologics Receives UK MHRA Approval for Trastuzumab Biosimilar Dazublys
CuraTeQ Biologics, a wholly owned step-down subsidiary of Aurobindo Pharma, has obtained marketing authorisation from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for its trastuzumab biosimilar, Dazublys.
HER2-positive Breast Cancer | 26/08/2025 | By Dineshwori | 199
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