News about "HER2-positive breast cancer"

Enhertu Secures US BTD Status in Early HER2-Positive Breast Cancer

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 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 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 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 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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