HER2-Positive Breast Cancer Treatment
Dec 26, 2025
ENHERTU Plus Pertuzumab Approved in Breast Cancer: First New First-Line Option in Over a Decade
The pharmaceutical landscape for HER2-positive metastatic breast cancer has undergone a significant transformation with the FDA's approval of ENHERTU (fam-trastuzumab deruxtecan-nxki) in combination with pertuzumab as a first-line treatment—marking the first new therapeutic option approved in more than a decade for...
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Oct 17, 2025
Seagen’s TUKYSA Powers Pfizer’s Next HER2-Positive Breast Cancer Milestone
Pfizer’s oncology pipeline has achieved a second positive phase III trial in HER2-positive breast cancer within roughly a year. This latest success involves TUKYSA, a HER2-targeted tyrosine kinase inhibitor that Pfizer acquired through its $43 billion purchase of Seagen. In patients with HER2-positive metastatic...
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Sep 16, 2025
Lion TCR Secures Triple FDA Milestones with IND Clearance for Chronic Hepatitis B; Corstasis Therapeutics Wins FDA Approval for ENBUMYST Nasal Spray to Treat Edema in CHF, Liver, and Kidney Disease; Amneal Gains FDA Approval for Sodium Oxybate Oral Solution in Narcolepsy Patients with Cataplexy and Excessive Daytime Sleepiness; Greenwich LifeSciences’ GLSI-100 Granted FDA Fast Track Designation; Akeso’s Ligufalimab Granted FDA Orphan Drug Designation for Acute Myeloid Leukemia
Lion TCR Secures Triple FDA Milestones for Chronic Hepatitis B with IND Clearance of TCR-T Therapy Lion TCR announced that the FDA has cleared its Investigational New Drug (IND) application for LioCyx-M004, authorizing the initiation of phase Ib/II clinical trials in patients with chronic hepatitis B (CHB). The ...
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Aug 13, 2024
Roche’s HER2-Positive Breast Cancer Treatment Franchise
For most of the last century, breast cancer was categorized only by its location in the body; as a result, treatment results varied significantly. Patients with metastatic HER2+ breast cancer were traditionally treated with conventional chemotherapy regimens until trastuzumab became available. In September 1998, th...
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