Spectrum to Cut 75% of Staff and NSCLC Program Following CLR

After receiving a Complete Response Letter (CLR) from the FDA for its non-small cell lung cancer drug (NSCLC), poziotinib, Spectrum Pharmaceuticals announced its intention to cease further development of the therapy while cutting approximately three-quarters of its research and development staff. The company said it plans to shift its focus to the recently approved chemotherapy infection-reduction drug, Rolvedon.

Poziotinib’s Room for Improvement

After years of development and clinical trials, Spectrum received the first significant blow to the poziotinib program in September when the Oncologic Drugs Advisory Committee (ODAC) expressed concerns about low overall response rates, minimal response duration, poorly tolerated safety profile, and inadequate dosage optimization. 

The FDA has the authority to overrule the ODAC recommendation, but, like in most cases, the regulatory authority stuck with ODAC’s advice, rejecting poziotinib’s accelerated approval application. Spectrum’s President and CEO, Tom Riga, said he is not surprised by the outcome but disappointed.

Riga also commented on poziotinib’s potential in the NSCLC area, saying that the company would be open to partnerships in the future to continue developing the product. For now, though, Spectrum is putting the therapy on the sideline. South Korean partner, Hanmi Pharmaceuticals, retains the rights to poziotinib in Korea and China and has not announced any plans to cease the therapy’s development in its facilities. 

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A Major Blow to Spectrum’s Staff

Along with the decision to discontinue poziotinib’s development, Spectrum announced its plans to cut about 75% of its research and development staff to lengthen its financial runway. Based on the anticipated cost savings from the restructuring, the company says it will be able to continue operations through 2024. 

With poziotinib out of the picture, Spectrum plans on focusing all of its efforts on Rolvedon, a recently approved therapy to reduce infections caused by chemotherapy. The FDA approved Rolvedon in September this year, and Spectrum says the potential market for the drug could be up to $2 billion.

In addition to commercialization and market efforts for Rolvedon, Spectrum is continuing development operations for the treatment in hopes of tacking on additional indications. According to the company’s pipeline, the drug is in phase 2 trials to determine its worth in pediatric patients treated with myelosuppressive chemotherapy. Rolvedon is also in phase 1 trials to assess the safety and efficacy of same-day dosing. 

Poziotinib’s accelerated approval rejection is a major setback for Spectrum. Still, with Rolvedon’s recent approval, the company will fight to stay afloat until the cash starts rolling in from the infection reduction therapy. The remaining quarter of the staff will have its work cut out to expand Rolvedon’s development, but it will no longer have poziotinib’s burden to carry. 

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Author

Reed Slater