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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 Pegfilgrastim
Neulasta · 16 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 |
| Aranesp | EXPERIMENTAL | - |
| Neulasta | EXPERIMENTAL | - |
| 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 |
| Neulasta | DRUG | 6mg Neulasta to be given approximately 24 hours afer each cycle of chemotherapy |
| Aranesp | DRUG | If Hb drops below 110, 300mcg Aranesp will be administered. |
| 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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Neulasta is studied in breast cancer as supportive care for women receiving chemotherapy. The Phase 2 ACCELERATE trial evaluated it alongside pegfilgrastim and darbepoetin alfa support in patients treated with doxorubicin and cyclophosphamide followed by paclitaxel. It is given to help manage blood cell counts during chemotherapy.
Neulasta is developed by Amgen Inc., which trades on Nasdaq under the ticker AMGN. Amgen is the sponsor behind the clinical program evaluating the drug in breast cancer.
Neulasta has been evaluated in a Phase 2 clinical trial in breast cancer. That study, ACCELERATE, is completed. Neulasta is an investigational agent in this setting and remains in clinical development rather than being an approved breast cancer therapy.
Neulasta was studied in the Phase 2 ACCELERATE trial, registered as NCT00261313. The trial enrolled 80 women aged 18 years and older with breast cancer and evaluated doxorubicin and cyclophosphamide followed by paclitaxel with pegfilgrastim and darbepoetin alfa support. The study is completed.
The ACCELERATE trial was a controlled Phase 2 study that enrolled 80 female participants aged 18 years and older with breast cancer. It was not randomized and not double blinded, and it used a biomarker-selected population. The trial is completed.