Spectrum Pharmaceuticals Inc. (NASDAQ: SPPI) shares dipped on Thursday after the firm announced a key update from the U.S. Food and Drug Administration (FDA).
Specifically, the firm announced that it had submitted a Biologics License Application (BLA) with the FDA for Rolontis (eflapegrastim). The submission is based on results from two large, positive pivotal trials.
The BLA for Rolontis is supported by data from two identically designed Phase 3 clinical trials, Advance and Recover, which evaluated the safety and efficacy of Rolontis in 643 early-stage breast cancer patients for the treatment of neutropenia due to myelosuppressive cytoxic chemotherapy.
The study Advance was conducted under a special protocol assessment with the FDA. In both studies, Rolontis demonstrated the pre-specified hypothesis of non-inferiority in duration of severe neutropenia (DSN) and a similar safety profile to pegfilgrastim. Rolontis also demonstrated non-inferiority to pegfilgrastim in the DSN across all four cycles in both studies.
Joe Turgeon, president and CEO of Spectrum, commented:
Rolontis is an important and significant future growth driver for our company. Today’s milestone brings us one step closer to bringing the first novel G-CSF to healthcare providers in over 15 years in a large market that is familiar to Spectrum.
Shares of Spectrum Pharma were last seen down about 11% at $8.47, in a 52-week range of $6.22 to $25.29. The consensus analyst price target is $28.50.
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