Spectrum Pharmaceuticals

Spectrum received a Complete Response Letter from FDA for Poziotinib.

Sep 22, 2022

Spectrum provided an update on Poziotinib following the FDA Oncologic Drugs Advisory Committee (ODAC) Meeting regarding Spectrum's New Drug Application (NDA).

The ODAC voted 9–4 against a Poziotinib approval as the advisers judged the drug's risks outweighed its benefits.

Feb 11, 2022

Spectrum announced FDA acceptance of the New Drug Application (NDA) submitted for Poziotinib

Dec 6, 2021

Spectrum submitted the New Drug Application (NDA) for Poziotinib.

Mar 11, 2021

FDA Grants Fast Track Designation (FTD) to Spectrum for Poziotinib.

Dec 19, 2018

Spectrum announced that based on a subset of data from MD Anderson's ongoing Phase 2 study, FDA did not grant Breakthrough Therapy Designation (BTD) to Poziotinib for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have EGFR exon 20 mutations.

Spectrum's BTD application included data from 30 patients from MD Anderson's Phase 2 study who had failed platinum-based chemotherapy.

Spectrum reported that the MDAnderson data demonstrated a confirmed objective response rate of 40% and median duration of response of 6.6 months.

Spectrum stated the safety profile in this subset was consistent with historical data published on poziotinib and other tyrosine kinase inhibitors. The historical objective response rates for mutation specific NSCLC patients range between 0% and 8% with tyrosine kinase inhibitors and for non-mutation specific NSCLC patients range between 0.8% and 22.9% with other treatments.

2018 Spectrum submits Poziotinib application for Breakthrough Therapy Designation (BTD) to FDA based on data reported on patients treated by John V. Heymach and medical staff at the MD Anderson Cancer Center.

Sep 24, 2018

Spectrum Announced the release of updated Poziotinib data From MD Anderson's Phase 2 Study in Non-Small Cell Lung Cancer Patients.

May 3, 2018

Patent Licensing Agreement announced by and between The University of Texas MD Anderson Cancer Center (MDACC) and Spectrum Pharmaceuticals to cover discoveries by John V. Heymach and Heymach's research staff at MDACC in the future.

The filed patents, if granted, are expected to extend the intellectual property protection to 2037.

Oct 27, 2017

Spectrum highlights Poziotinib Data in Non-Small-Cell Lung Cancer (NSCLC) from research results reported by John V. Heymach and The University of Texas MD Anderson Cancer Center.

At the 18th IASLC World Conference on Lung Cancer in Japan, Spectrum presented data reported by Heymach and the MD Anderson Cancer Center research team illustrating that Poziotinib demonstrated evidence of significant antitumor activity in NSCLC patients with EGFR exon 20 insertion mutations, with interim data showing an Objective Response Rate of 73%.

Evidence of central nervous system (CNS) activity in a patient with CNS metastasis and another with leptomeningeal disease (LMD).

March 17, 2017

First Poziotinib clinical trial patient enrolled by John V. Heymach into the Investigator Study Protocol 2016–0783.

Feb. 23, 2017

John V. Heymach initiated the Investigator IND as the Study Sponsor to of the clinical research, Protocol 2016–0783, “A Phase II Study of Poziotinib in EGFR or HER2 Mutant Advanced Solid Tumors” in collaboration with Spectrum and National Cancer Institute (NCI).