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

Rolontis, Spectrum's first 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
Spectrum Pharmaceuticals, Inc. An International Commercial-Stage Biotechnology Company

Market Opportunities


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

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

Mode of Action

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

Rolontis Mechanism of action


  • The Phase 3 ADVANCE Study met the primary efficacy endpoint of non-inferiority in Duration of Severe Neutropenia between ROLONTIS and pegfilgrastim; adverse event profile was similar between the two treatment arms.
  • RECOVER, the second Phase 3 study, is fully enrolled. The Company plans to file a Biologics License Application (BLA) in fourth quarter of this year.
  • A pivotal Phase 3 study (ADVANCE) was initiated under an SPA from the FDA in 2016 to evaluate ROLONTIS in the management of chemotherapy-induced neutropenia. Based on the amended SPA, the size of the ADVANCE study was reduced to 400 from 580 evaluable patients.
  • An additional Phase 3 study (RECOVER) has been initiated to help strengthen the regulatory package in the U.S. and Europe. A 218 patient study, called the RECOVER Trial, is expected to include sites not only from the U.S., but also from Europe, Canada and South Korea.
  • Made decision to advance ROLONTIS to Phase 3 due to positive Phase 2 results in September 2014.
  • Additional information on the RECOVER trial can be found at the RECOVER Patient web site here and the Investigators site here.

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