FDA Issues CRL for Poziotinib for Lung Cancer


An advisory committee had voted against poziotinib to treat patients with non-small cell lung cancer with HER2 exon 20 insertion mutations.

The FDA has issued a complete response letter for Spectrum Pharmaceuticals’ new drug application (NDA) for poziotinib, which was being reviewed to treat patients with previously treated locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring HER2 exon 20 insertion mutations.

The FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 9 to 4 on Sept. 22, 2022, against on whether the benefits of Spectrum Pharmaceuticals’ poziotinib outweigh its risks. Several concerns factored into the decision, including a low overall response rate and high rate of adverse events, a dose that was not optimized and a confirmatory trial that will not likely see results until 2026.

Related: FDA Advisory Committee Votes Against Poziotinib for NSCLC

Tom Riga

Tom Riga

“While we are not surprised by the CRL given the ODAC recommendation in September, we are disappointed.” Tom Riga, president and chief executive officer of Spectrum Pharmaceuticals said in a press release. “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.”

Riga said the company has made the decision to immediately de-prioritize the poziotinib program. Based on the CRL, the company would have to generate additional data including a randomized controlled study prior to approval. Instead, Spectrum will explore potential strategic alternatives, including partnerships and business development opportunities.

As a result, Spectrum is reducing its R&D workforce by about 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.

The company is focused now on the recently launched Rolvedon, Riga said. The FDA in September 2022 approved Rolvedon (eflapegrastim-xnst) injection to decrease infection in patients receiving myelosuppressive anti-cancer drugs. Previously named Rolontis, Rolvedon is indicated for adult patients with non-myeloid malignancies.

Rolvedon is a long-acting granulocyte colony-stimulating factor (G-CSF) with a novel formulation. It comprises two protein components — an analog of G-CSF and an Fc antibody fragment — tethered by a flexible polyethylene-glycol linker. It uses the company’s LAPSCOVERY technology with a differentiated molecular structure.

Related: FDA Approves Rolvedon to Prevent Chemotherapy-related Infections

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