Spectrum Pharmaceuticals, Inc. An International Commercial-Stage Biotechnology Company
Spectrum Pharmaceuticals, Inc. An International Commercial-Stage Biotechnology Company
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RolontisTM (eflapegrastim)

Eflapegrastim, Spectrum's third biological drug, is a long-acting Granulocyte-Colony Stimulating Factor (G-CSF) that utilizes Hanmi Pharmaceutical Co., Ltd. proprietary platform technology, LAPSCOVERY1.

Chemotherapy can cause myelosuppression and unacceptably low levels of white blood cells, making patients prone to infections, hospitalizations, and interruption of additional chemotherapy treatments. G-CSF stimulates proliferation of granulocyte progenitors and subsequent production of neutrophils in the bone marrow. A recombinant form of G-CSF is used in appropriate cancer patients to accelerate recovery from neutropenia after chemotherapy, allowing higher-intensity treatment regimens to be given at full-dose and on schedule.

Target Indications

  • Chemotherapy-induced neutropenia

Route of Administration

  • Subcutaneous injection

Mode of Action

Binds to the G-CSF receptor expressed on granulocyte progenitors and stimulates their proliferation and subsequent maturation to functionally active neutrophils.

Eflapegrastim Mechanism of action

Status

  • Under a Special Protocol Assessment (SPA), a pivotal Phase 3 study was initiated in Q1 2016 and will evaluate eflapegrastim as a treatment for chemotherapy-induced neutropenia in approximately 580 patients with breast cancer. Click here to view trial details on Clinical Trials.gov
  • Made decision to advance eflapegrastim to Phase 3 due to positive Phase 2 results in September 2014.
  • A Phase 2 multicenter, dose-ranging study that evaluated the effectiveness and safety of eflapegrastim relative to a fixed, standard dose of pegfilgrastim as a concurrent active control was initiated in 2013.
  • Overall, in the Phase 1 studies in healthy volunteers, it was concluded that eflapegrastim had an acceptable safety profile and increased white blood cell (WBC) and neutrophil counts in a pronounced and dose-dependent manner.
  • 1. LAPSCOVERY is a trademark of Hanmi Pharmaceutical Co., Ltd.

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Spectrum Pharmaceuticals, Inc. An International Commercial-Stage Biotechnology Company

Market Opportunities

Eflapegrastim

Eflapegrastim is being tested for granulocyte recovery in patients with chemotherapy induced neutropenia, a multibillion dollar worldwide market.

If eflapegrastim is ultimately commercialized, Spectrum shall own worldwide rights except for Korea, China, and Japan.