Spectrum Pharmaceuticals, Inc.

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Spectrum Provides Poziotinib Update After Successful Pre-NDA Meeting With FDA

Published: 12/22/2020 21:19 GMT
Spectrum Pharmaceuticals, Inc. (SPPI) - Spectrum Provides Poziotinib Update After Successful Pre-nda Meeting With the FDA.
Spectrum - FDA Agrees to Submission of an NDA for Poziotinib for Nsclc in Previously Treated Patients With Her2 Exon 20 Insertion Mutations.
Spectrum Pharmaceuticals Inc - NDA Submission Planned for 2021 for Poziotinib for Non-small Cell Lung Cancer.
Spectrum Pharmaceuticals Inc - Cohort 3 of Zenith20 Clinical Trial Did Not Meet Its Primary Endpoint.
Spectrum - Preliminary Data From Patients Receiving 8 Mg of Poziotinib Twice Daily Demonstrated Meaningful Improvement in Tolerability.
Spectrum - Confirmed With FDA That Cohort 2 Data Could Serve As Basis of an NDA Submission for Poziotinib for Non-small Cell Lung Cancer.
Spectrum - While Cohort 3 Did Not Meet Pre-specified Orr Endpoint, We Are Seeing Evidence of Clinical Activity With Disease Control Rate (dcr) of 86%.
Spectrum - While Cohort 3 Did Not Meet Orr Endpoint, We Are Seeing Evidence of Clinical Activity With Progression Free Survival Data of 7.2 Months.
Spectrum - 94% of Patients Had Drug Interruptions With 6 Patients Permanently Discontinuing Due to Adverse Events in Cohort 3 of Zenith20 Trial.