USFDA declines to approve Spectrum Pharma lung cancer drug Poziotinib

USFDA declines to approve Spectrum Pharma lung cancer drug Poziotinib

USA: Spectrum Pharmaceuticals, Inc., a biopharmaceutical company focused on novel and targeted oncology therapies, has announced that the Company has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (USFDA) regarding Spectrum's New Drug Application (NDA) for poziotinib for the treatment of patients with previously treated locally advanced or metastatic non-small cell lung cancer ("NSCLC") harboring HER2 exon 20 insertion mutations.

The USFDA has issued a CRL indicating the poziotinib application cannot be approved in its present form. Based on the CRL, the Company would have to generate additional data including a randomized controlled study prior to approval.

"While we are not surprised by the CRL given the ODAC recommendation in September, we are disappointed. After multiple interactions with the USFDA since ODAC, and following careful consideration, we have made the strategic decision to immediately de-prioritize the poziotinib program," said Tom Riga, President and Chief Executive Officer of Spectrum Pharmaceuticals.

"We continue to believe that poziotinib could present a meaningful treatment option for patients with this rare form of lung cancer, for whom other therapies have failed."

Mr. Riga continued, "We are committed to exploring potential strategic alternatives for poziotinib, including partnerships and business development opportunities, and will determine the best path forward in support of patients.

We are grateful to the patients, families, and clinicians who participated in the poziotinib program and to the team members who have dedicated their time and efforts."

The Company will de-prioritize poziotinib program activities, effective immediately, and is in the process of reducing its R&D workforce by approximately 75%.

Based on the anticipated cost savings from the restructuring, Spectrum believes it will be able to generate the working capital required to support its strategic refocusing through 2024.

USFDA declines to approve Spectrum Pharma lung cancer drug Poziotinib:

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