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Label indication Neulasta is a leukocyte growth factor indicated to Decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. FDA label
Also known as Injection of Pegfilgrastim, of Pegfilgrastim, Neulasta®
Pegfilgrastim · 15 trials · 21 indications
Grade 3/4 febrile neutropenia (FN) is defined as: • A temperature ≥ 38.0°C (≥ 100.4°F) and absolute neutrophil count (ANC) \< 1.0 × 10\^9/L, where ANC was measured the same day or within ± 1 calendar day of a temperature ≥ 38.0°C (≥ 100.4°F), or • An ANC \< 1.0 × 10\^9/L in combination with: - documented sepsis or infection, OR - neutropenia-related hospitalization where ANC was measured the same day or within ± 1 calendar day. Participants monitored their oral temperatures and maintained diaries to record their temperature twice per day: once in the morning and once in the evening, as well as whenever they suspect they had fever throughout the first 4 cycles of chemotherapy treatment.
Bone pain data were captured as part of standard adverse event (AE) reporting.
Pathological response is defined as down-staging to \</=pT1, N0 after chemotherapy with pegfilgrastim support.
Grade 3 or 4 neutropenia, defined as an absolute neutrophil count (ANC) \< 1 x 10\^9/L, in any of the first four cycles of treatment
Grade 4 neutropenia, defined as an absolute neutrophil count (ANC) \<0.5 x 10\^9/L, in any of the first four cycles of treatment
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Participants received standard chemotherapy (FOLFOX or FOLFIRI) on Days 1-2, and bevacizumab 5 mg/kg intravenous (IV) infusion on Day 1 of each 14-day cycle plus placebo subcutaneous injection once per cycle, for a maximum of 4 cycles, 24 hours after chemotherapy (Day 4). |
| Pegfilgrastim | PLACEBO_COMPARATOR | Participants received standard chemotherapy (FOLFOX or FOLFIRI) on Days 1-2 and bevacizumab 5 mg/kg intravenous (IV) infusion on Day 1 of each 14-day cycle plus pegfilgrastim 6 mg administered as a single subcutaneous injection once per cycle, for a maximum of 4 cycles, 24 hours after chemotherapy (Day 4). |
| Filgrastim | ACTIVE_COMPARATOR | Daily subcutaneous administration of Filgrastim (Neupogen® - Laboratory AMGEN) 5 µg/kg/day from D5 until recovery from aplasia (PNN \> 0.5 G/L) |
| Prophylactic naproxen | EXPERIMENTAL | Participants received adjuvant or neoadjuvant chemotherapy with pegfilgrastim prophylaxis in addition to prophylactic naproxen 500 mg orally twice a day (BID) for 5 days in each of the 4 cycles, beginning on the day of pegfilgrastim administration. |
| Prophylactic loratadine | EXPERIMENTAL | Participants received adjuvant or neoadjuvant chemotherapy with pegfilgrastim prophylaxis in addition to prophylactic loratadine 10 mg once a day (QD) for 5 days in each of the 4 cycles, beginning on the day of pegfilgrastim administration. |
| No prophylactic treatment | OTHER | Participants received adjuvant or neoadjuvant chemotherapy with pegfilgrastim prophylaxis. |
| Dose Dense MVAC | EXPERIMENTAL | Chemo therapy with methotrexate, vinblastine, Adriamycin, Cisplatin |
| Pegfilgrastim 6 mg | EXPERIMENTAL | Pegfilgrastim 6 mg given once for PBPC mobilization |
| Pegfilgrastim 12 mg | EXPERIMENTAL | Pegfilgrastim 12 mg given once for PBPC mobilization |
| Arm A | ACTIVE_COMPARATOR | Pegfilgrastim |
| Arm B | ACTIVE_COMPARATOR | Pegfilgrastim |
| Pegfilgrastim 18 mg | EXPERIMENTAL | Pegfilgrastim 18 mg given once for mobilization |
| Name | Type | Description |
|---|---|---|
| Pegfilgrastim | DRUG | Administered as a single 6 mg subcutaneous injection using a pre-filled syringe. There will be no dosage adjustments for investigational product. |
| Placebo | DRUG | Administered as a single subcutaneous injection using a pre-filled syringe. |
| Bevacizumab | BIOLOGICAL | 5 mg/kg by intravenous (IV) infusion on day 1 of each 14-day cycle. |
| Standard Chemotherapy | DRUG | Each participant received one of the following chemotherapy regimens at the discretion of treating physician: FOLFOX: Oxaliplatin, leucovorin, and 5-fluorouracil; FOLFIRI: Irinotecan, leucovorin and 5-flurouracil. |
| Injection of Pegfilgrastim | DRUG | Single subcutaneous administration of Pegfilgrastim (Neulasta® - Laboratory AMGEN) 6 mg at D5 |
| Injection of Filgrastim | DRUG | Daily subcutaneous administration of Filgrastim (Neupogen® - Laboratory AMGEN) 5 µg/kg/day from D5 until recovery from aplasia (PNN \> 0.5 G/L) |
| Naproxen | DRUG | - |
| Loratadine | DRUG | - |
| Chemotherapy | DRUG | The choice of chemotherapy regimen (agent, dose, and schedule) is at the discretion of the treating physician. |
| Methotrexate | DRUG | intravenously 30mg/m2 over 30 minutes |
| Doxorubicin | DRUG | intravenously 30mg/ms over 15 minutes |
| vinblastine | DRUG | intravenously 3mg/m2 over 30 minutes |
| cisplatin | DRUG | intravenously 70mg/m2 in 1 liter NS with 12.5gm Mannitol over 2 hours after vinblastine completion |
| pegfilgrastim 12 mg | DRUG | Pegfilgrastim 12 mg given once for PBPC mobilization |
| filgrastim | DRUG | Filgrastim given daily for PBPC mobilization |
| pegfilgrastim 6 mg | DRUG | Pegfilgrastim 6 mg given once for PBPC mobilization |
| carboplatin | DRUG | Chemotherapy |
| paclitaxel | DRUG | chemotherapy |
| docetaxel | DRUG | - |
| cyclophosphamide | DRUG | - |
| 5-fluorouracil | DRUG | - |
Inclusion Criteria: Disease-related: * Histologically or cytologically-confirmed adenocarcinoma of the colon or rectum * Locally-advanced or metastatic disease by radiographic evaluation * Measurable disease * Has not previously received chemotherapy for locally-advanced or metastatic colorectal c...
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Pegfilgrastim is a small molecule developed by Amgen Inc. (AMGN) that acts as an agonist of CSF3R. It is being studied in oncology across indications including bladder cancer, breast cancer, colon cancer, lymphoma, and cancer-related bone pain. It is investigational and has been evaluated in four completed clinical trials.
Pegfilgrastim targets CSF3R as an agonist. By activating this receptor, it is designed to stimulate granulocyte colony-stimulating factor signaling, which supports neutrophil production and mobilization. This mechanism underlies its study in cancer settings where neutropenia or stem cell mobilization is a concern.
Pegfilgrastim is developed by Amgen Inc., which trades under the ticker AMGN. Amgen is the sponsor of the clinical trials evaluating pegfilgrastim in oncology indications such as bladder cancer, breast cancer, colon cancer, and lymphoma.
Pegfilgrastim is in Phase 2 development. It is investigational and has not been approved by the FDA for the indications studied. Four clinical trials have been completed, with no active trials currently reported. The completed trials include Phase 2 and Phase 3 studies.
Pegfilgrastim has been evaluated in four completed trials: NCT01712009 (NOLAN, Phase 2, bone pain in breast cancer), NCT00911170 (PAVES, Phase 3, colorectal cancer), NCT00808639 (Phase 2, muscle-invasive bladder cancer), and NCT00794261 (Phase 2, lymphoma and myeloma). All trials are completed and no active trials are reported.