News about "HER2-positive breast cancer"

US FDA Approves Tucatinib for HER2-Positive Breast Cancer

The US FDA has approved tucatinib with trastuzumab and pertuzumab for the maintenance treatment of HER2-positive breast cancer.

HER2-positive Breast Cancer | 08/10/2026 | By News Bureau |  222

Formosa Pharmaceuticals Files Clinical Trial Application for TSY-110 HER2 ADC Biosimilar

Formosa Pharmaceuticals files a clinical trial application for TSY-110, a HER2-targeting Antibody Drug Conjugate (ADC) biosimilar positioned as a potential alternative to Roche’s Kadcyla.

HER2-positive Breast Cancer | 01/09/2026 | By News Bureau

Enhertu Plus Pertuzumab Approved in China for First-Line HER2-Positive Metastatic Breast Cancer

Enhertu plus pertuzumab has been approved in China as first-line treatment for HER2-positive metastatic breast cancer, based on positive phase 3 results.

HER2-positive Breast Cancer | 13/08/2026 | By News Bureau |  140

EMA Committee Recommends Approval of AstraZeneca and Daiichi Sankyo's Enhertu Plus Pertuzumab

If approved, AstraZeneca and Daiichi Sankyo’s Enhertu plus pertuzumab would become first new treatment in the European Union (EU) in more than a decade for first-line HER2-positive metastatic breast cancer.

HER2-positive Breast Cancer | 25/07/2026 | By News Bureau |  108

US FDA Approves Pfizer's Ibrance for Maintenance Treatment of HR+, HER2+ Metastatic Breast Cancer

FDA approval makes Ibrance the first CDK4/6 inhibitor indicated for HR+ metastatic breast cancer regardless of HER2 status.

HER2-Positive Breast Cancer | 26/06/2026 | By News Bureau |  282

CDSCO Approves AstraZeneca's Trastuzumab Deruxtecan Plus Pertuzumab Combination

AstraZeneca Pharma India has received CDSCO approval for trastuzumab deruxtecan plus pertuzumab as a first-line treatment for adults with unresectable or metastatic HER2-positive breast cancer.

HER2-positive Breast Cancer | 12/06/2026 | By News Bureau |  126

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 |  196

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 |  522

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 |  615

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 |  471