Venkateswara Reddy Sane, Immuno-Oncology and Hemato-Oncology Professional, shared on LinkedIn:
“FDA Approves Tucatinib + Trastuzumab + Pertuzumab for Maintenance Treatment in HER2-Positive Breast Cancer
The U.S. FDA has approved tucatinib in combination with trastuzumab and pertuzumab for the maintenance treatment of adults with unresectable, locally advanced or metastatic HER2-positive breast cancer following induction treatment.
- Supported by the HER2CLIMB-05 Phase III study
- Evaluated in 654 patients with HER2-positive advanced breast cancer
- Included patients with or without brain metastases
- Median PFS: 24.9 months vs 16.3 months
- Hazard ratio: 0.64
- OS data were not mature at the time of the PFS analysis
This approval represents an important development in HER2-directed maintenance therapy and further expands treatment strategies for advanced HER2-positive breast cancer.
Read the full FDA update: FDA – Tucatinib with Trastuzumab and Pertuzumab.
Disclaimer: This post is intended for educational and scientific communication based on publicly available information. It is not intended to promote, advertise, endorse, or recommend any medicine, product, treatment, or company, and does not constitute medical advice or a treatment recommendation.
Please refer to the original FDA communication and approved prescribing information for complete details.”
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