NEW YORK, Nov. 25, 2022 (GLOBE NEWSWIRE) — Kaplan Fox & Kilsheimer LLP (www.kaplanfox.com) is continuing to investigate claims on behalf of investors in Spectrum Pharmaceuticals, Inc. (“Spectrum” or the “Company”) (NASDAQ: SPPI) securities.
If you purchased Spectrum securities and would like to discuss our investigation, please contact us by emailing firstname.lastname@example.org or by calling (212) 329-8571.
On November 25, 2022, the Company disclosed that “that the Company has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) 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 FDA 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 FDA 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.”
Previously, on September 22, 2022, Reuters reported that advisers to the U.S Food and Drug Administration “voted against recommending Spectrum Pharmaceuticals’ (SPPI.O) experimental drug for the treatment of patients with a form of non-small cell lung cancer. The FDA panel voted 9 to 4 against the oral drug, poziotinib, citing marginal efficacy, high level of toxicities, and lack of dose optimization. The panel’s decision was in-line with briefing documents released by the drug regulator on Tuesday that raised concerns over the efficacy of the treatment compared with existing drugs like Daiichi Sankyo’s (4568.T) and AstraZeneca’s Enhertu. read more.”
Following this news, Spectrum’s stock price declined from a closing price on September 22, 2022 of $0.63 per share, to close at $0.43 per share, a decline of over 31% per share on heavy volume.
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