Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Neulasta · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Aranesp | EXPERIMENTAL | - |
| Neulasta | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| 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. |
Inclusion Criteria: * Breast cancer diagnosis node-positive or high risk node negative * Estrogen receptor (ER) negative or ER positive (stage IIA, IIB or IIIA) disease. Exclusion Criteria: * Metastatic breast cancer * Clinically significant cardiac disease
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Neulasta is used in breast cancer to support patients receiving chemotherapy. In the ACCELERATE trial, it was given with doxorubicin and cyclophosphamide followed by paclitaxel, along with darbepoetin alfa support, for the treatment of women with breast cancer. It is an investigational small molecule being studied for this indication.
Neulasta targets the granulocyte colony-stimulating factor receptor, which stimulates the production of neutrophils in the bone marrow. This helps reduce the risk of infection in patients undergoing chemotherapy. The drug is being studied in breast cancer to support white blood cell counts during treatment.
Neulasta is developed by Amgen Inc., a biotechnology company traded on the NASDAQ under the ticker AMGN. Amgen is conducting clinical research to evaluate the drug's safety and efficacy in breast cancer patients receiving chemotherapy.
Neulasta is in Phase 2 clinical development for breast cancer. It is an investigational drug and has not been approved by regulatory authorities for this use. The Phase 2 trial, ACCELERATE, has been completed with 80 female participants aged 18 years and older.
Neulasta is being studied in the ACCELERATE trial, registered as NCT00261313. This Phase 2 study evaluated doxorubicin and cyclophosphamide followed by paclitaxel with pegfilgrastim and darbepoetin alfa support in women with breast cancer. The trial enrolled 80 participants and has been completed.
Neulasta is the brand name for pegfilgrastim, a pegylated form of filgrastim. In the ACCELERATE trial, Neulasta is referred to as pegfilgrastim. It is a small molecule being studied for its supportive role in breast cancer chemotherapy.