Spectrum's Rolontis, angling to rival Amgen's Neulasta, hit with FDA rejection over manufacturing 'deficiencies'

Spectrum Pharmaceuticals’ neutropenia candidate Rolontis certainly hasn’t had the easiest trip through the FDA. On Friday, the company unveiled another setback.

The FDA turned down Rolontis’ application to treat neutropenia in cancer patients on myelosuppressive therapies. In a complete response letter, the FDA raised issues with manufacturing “deficiencies” and flagged the need for a site reinspection, Spectrum said in a release.

The company didn’t elaborate on what those deficiencies were or when the reinspection would take place. Spectrum says it’s seeking “further clarification” from the FDA and plans to meet with the regulator “as soon as possible” to get a handle on the situation.

The FDA didn't request any additional trials or raise any clinical issues in its letter, a Spectrum spokesperson said over email.

While “disappointed” by the decision, Spectrum is eager to get a sense of the “remediation timelines for the program,” Joe Turgeon, president and CEO at Spectrum, said in a statement. The company remains confident in its medicine and plans to “diligently complete” the regulatory process in hopes of scoring the drug its green light, he added.

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It’s far from Rolontis’ first stumble on the path toward approval. The FDA postponed its decision on the drug back in October after COVID-19 travel restrictions kept it from finishing an inspection of a South Korean bioplant operated by local drugmaker Hanmi. That company licensed the drug to Spectrum.

Hanmi’s domestic application process was still on track at that time, the Korea Biomedical Review reported. In March, Korea’s Ministry of Food and Drug Safety granted the drug its green light, the publication reported.

Before that hiccup, Spectrum pulled its Rolontis application in early 2019 after the FDA called for more information on the drug’s chemistry, manufacturing and controls process. 

If approved, Rolontis would be butting heads with Amgen’s neutropenia blockbuster Neulasta, which generated $2.29 billion in full-year sales for 2020.

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For Spectrum, the Rolontis delays are particularly stinging given that the company recently refocused its efforts on the med's development. In January 2019, Spectrum sold off its entire portfolio of seven marketed products to a subsidiary of India’s Aurobindo. The deal teed up Spectrum to receive $160 million upfront and up to $140 million in regulatory and sales-based milestones.

Unburdened by that portfolio, the company turned its attention to the development of Rolontis and its cancer med poziotinib.