Spectrum Pharma (SPPI) Says FDA Committee Voted 9-4 That Poziotinib’s Current Benefits Do Not Outweigh Its Risks

By Judy J. Beasley Last updated Dec 18, 2022

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Spectrum Pharmaceuticals (NasdaqGS: SPPI) (“Spectrum” or the “Company”), a biopharmaceutical company specializing in novel and targeted oncology therapies, today announced that the Oncology Drug Advisory Committee (“ODAC”) of the United States Food and Drug Administration (“FDA”) has met to review poziotinib for the treatment of patients with previously treated locally advanced or metastatic non-small cell lung cancer (“NSCLC”) harboring insertion mutations of HER2 exon 20. The committee voted 9 to 4 that the actual benefits of poziotinib did not outweigh its risks.

“We are disappointed with the results of the ODAC meeting, as patients with NSCLC HER2 exon 20 insertion mutations need additional effective and safe therapies,” said Tom Riga, President and CEO. from the management of Spectrum Pharmaceuticals. “We plan to carefully evaluate our options for this program as the November 24, 2022, PDUFA date approaches. We would like to thank the lung cancer patients and their families, as well as the researchers and their staff, for their support.

The ODAC is an independent panel of experts that reviews and evaluates data regarding the efficacy and safety of marketed and investigational products for the treatment of cancer. The committee makes appropriate recommendations to the FDA, but these recommendations are not binding and the final decision regarding product approval will be made solely by the FDA.

About poziotinib

Poziotinib is a novel oral epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI) that inhibits the tyrosine kinase activity of EGFR as well as HER2 and HER4, which in turn leads to the inhibition of the proliferation of tumor cells that overexpress these receptors. Mutations or overexpression/amplification of EGFR family receptors have been linked to a number of different cancers, including non-small cell lung cancer (NSCLC), breast cancer, and gastric cancer. HER2 exon 20 insertion mutations are a rare subset representing approximately 2-4% of NSCLC cases. There are no approved treatments for treatment-naïve or previously treated NSCLC with HER2 exon 20 insertion mutations. Spectrum Pharmaceuticals holds an exclusive license from Hanmi Pharmaceutical (“Hamni”) to develop, manufacture and commercialize poziotinib worldwide, excluding Korea and China. Poziotinib is currently being studied by the Company and Hanmi in several mid-stage trials in multiple solid tumor indications.

About Spectrum Pharmaceuticals, Inc.

Spectrum Pharmaceuticals is a biopharmaceutical company focused on acquiring, developing and commercializing novel and targeted oncology therapies. Spectrum has a strong track record of successfully executing across the entire biopharmaceutical business model, from in-licensing and acquiring differentiated drugs, clinical development of new assets, successfully obtaining regulatory approvals and commercialization. in a competitive healthcare market. Spectrum has a late-stage pipeline with new assets that address unmet needs. This pipeline has the potential to transform the Company in the near future. For more information about Spectrum Pharmaceuticals, please visit www.spirx.com.

Notice Regarding Forward-Looking Statements – Spectrum Pharmaceuticals

Certain statements contained in this press release may constitute “forward-looking statements” within the meaning of the United States Private Securities Litigation Reform Act of 1995, as amended to date. These forward-looking statements address a variety of matters, including, but not limited to, statements relating to Spectrum’s business and its future, including the likelihood and timing of FDA approval of poziotinib, if FDA approval is received, the success and timing of the Company’s commercialization efforts, the results of the confirmatory study for poziotinib, the potential therapeutic benefits of poziotinib, the potential market opportunity for the poziotinib, the future potential of Spectrum’s existing drug pipeline and other statements that are not purely statements of historical fact. These forward-looking statements are made based on the current beliefs, expectations and assumptions of Spectrum’s management and are subject to important risks and uncertainties that could cause actual results to differ materially from what may be expressed or implied. in these forward-looking statements. – look at the statements. Risks that could cause actual results to differ include, but are not limited to, the possibility that poziotinib may not be more effective, safer, or more cost-effective than competing drugs, our dependence on third parties for clinical trials, manufacturing, distribution and quality control, the possibility that our existing and new applications with the FDA and other regulatory agencies may not receive approval in a timely manner or at all, the possibility that our efforts to acquire or in-license and develop additional drug candidates will fail and other risks which are described in more detail in the Company’s filings with the Securities and Exchange Commission (SEC). The Company does not intend to update these forward-looking statements and expressly disclaims any obligation to update the information contained in this press release, except as required by law. For a more in-depth discussion of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Spectrum’s business generally, see the risk information in the annual report. on Spectrum’s Form 10-K for the fiscal year ended December 31, 2021, as well as in subsequent reports on Forms 10-Q and 8-K and other filings with the SEC by Spectrum.

SPECTRUM PHARMACEUTICALS, INC.® is a registered trademark of Spectrum Pharmaceuticals, Inc and its subsidiary. REDEFINING CANCER CARE™ and the Spectrum Pharmaceuticals logos are registered trademarks owned by Spectrum Pharmaceuticals, Inc. All other trademarks are the property of their respective owners.

Show source version on businesswire.com: https://www.businesswire.com/news/home/20220922005870/en/

Spectrum contacts:

Tom Riga

Chief executive officer

949.788.6700

[email protected]

Lisa Wilson

Onsite Communications, Inc.

212.452.2793

[email protected]

Source: Pharmaceutical Spectrum