Category: breakthrough Therapy

  • Enhertu gets breakthrough tag in HER2-low breast cancer

    AstraZeneca and Daiichi Sankyo have claimed a fifth breakthrough designation from the FDA for Enhertu, shortly after the showing the drug extended survival in patients with HER2-low metastatic breast cancer. The coveted status has been awarded to the HER2-targeting antibody-drug conjugate (ADC) on the back of the DESTINY-Breast04 trial results, unveiled in February, which involved […]

  • FDA gives Daiichi Sankyo’s HER3 drug a breakthrough tag

    Daiichi Sankyo has been granted breakthrough status by the FDA for patritumab deruxtecan, a HER3-targeted antibody-drug conjugate (ADC) in clinical trials for lung cancer. The designation – which is awarded to  therapies that could represent a significant improvement over standard of care in either efficacy, safety, or both – has been awarded on the strength […]

  • Enhertu nabs speedy FDA review for earlier use in breast cancer

    Hard on the heels of impressive new data for Enhertu as a second-line therapy for breast cancer, AstraZeneca and Daichi Sankyo have claimed FDA breakthrough status for the drug that should shorten its review time. The new designation for Enhertu (trastuzumab deruxtecan) is based on the results of the DESTINY-Breast03 trial, which showed that the […]