FDA, Regulatory, Setbacks

Spectrum yanks marketing application for Neulasta rival after FDA demands more data

Months after Spectrum Pharmaceuticals informed investors that the FDA had denied its lung cancer drug poziotinib the breakthrough therapy status tag, the drugmaker said it is rescinding the marketing application for its lead experimental drug to accommodate the US agency’s request for more manufacturing data.

The BLA for the drug, eflapegrastim (to be sold as Rolontis), will be submitted as soon as possible, Spectrum said, noting that the FDA’s request did not include additional clinical studies. The additional manufacturing-related information was required before March 29, 2019 — the day that the FDA’s initial 60-day review period ends — and the company needs more time, it said.

The Henderson, Nevada-based company’s shares $SPPI were down about 7.6% at $9.50 in pre-market trading.

The treatment is under review for chemotherapy-induced neutropenia, a condition characterized by low levels of a white blood cell called neutrophils. In the United States, Amgen’s flagship neutropenia drug Neulasta continues to dominate the market, despite a flux of biosimilar competition.

In an initiation note published by Jefferies’ Maury Raycroft on Friday, the analyst suggested Rolantis’ approval as a branded drug “could compete directly with Neulasta and chip away at a large market (estimated more than $4 billion).”

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Sr. Manager, Regulatory Affairs, CMC
CytomX Therapeutics San Francisco, CA
Marketing Associate - Demand Generation
Catalytic Data Science Charleston, SC
Associate Principal, Life Sciences Partnerships
Flatiron Health New York City or San Francisco

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