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    CDE Accepted Alpha Biopharma's New Drug Application for Zorifertinib, a Next-Generation EGFR-TKI to Treat EGFR-Mutated NSCLC Patients with CNS Metastase...

    Details:

    AZD-3759 (zorifertinib) is a potent, oral, reversible, next-generation mutated EGFR-TKI with full blood-brain barrier penetration targeting advanced NSCLC patients with CNS metastases and EGFR-sensitizing mutations.


    Lead Product(s): Zorifertinib

    Therapeutic Area: Oncology Product Name: AZD-3759

    Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule

    Partner/Sponsor/Collaborator: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable January 29, 2023

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    Alpha Biopharma Announces Completion of its EVEREST Phase II/III Clinical Study of Zorifertinib in Non-Small Cell Lung Cancer Patients with Central Nerv...

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    The clinical and preclinical data of Zorifertinib have shown its high blood-brain barrier (BBB) penetration, anti-tumor activity in metastatic CNS lesions, overall efficacy in both CNS and extra-cranial diseases, and similar safety profile as other EGFR-TKI drugs. I


    Lead Product(s): Zorifertinib

    Therapeutic Area: Oncology Product Name: AZD-3759

    Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule

    Partner/Sponsor/Collaborator: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable August 24, 2022

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