What is a Biologic?
The FDA considers a biologic to be any therapeutic serum, toxin, antitoxin, vaccine, virus, blood, blood component or derivative, allergenic product, or analogous product, or derivatives applicable to the prevention, treatment, or cure of injuries or disease of man.
Resources
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Presentation: Growth factors in cancer care curetoday.com pdf
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Safety Information on Therapeutic Biological Products FDA.gov
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Name
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Description & Links
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CpG
Stimulates immunity
Related Abstracts
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CpG oligonucleotides
Main purpose: Experimental; immune modulator
"CpG activates the immune system in the way it evolved to be activated, by detection of bacterial products. You activate a well-orchestrated symphony of responses that synergize with each other." Everything enters on cue: cells, cytokines, and actions. Toxicity is minimal. Immune factors, although great medicines, drive "an artificial, disorganized response. You have to use very high doses to get any activity, and because of that, you also get a lot of toxicity." Sponsor's description
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Background: Coley Toxin's Hidden Message From a 19th century mystery comes a potential new class of drugs: CpG oligonucleotides
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Boosting Mabs and vaccines? CpG-DNA activates dendritic cells in vivo: T helper cell-independent cytotoxic T cell responses to soluble proteins. Eur J Immunol. 2000 Dec;30(12):3591-7 Related abstracts
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G-CSF
Stimulates blood cell development
Neupogen®
(filgrastim)
Neulasta ®
(pegfilgrastim)
Related Abstracts
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Granulocyte Colony Stimulating Factor
Main purpose: Treatment of neutropenia (low white blood cell counts)
Use in myelosuppressive chemotherapy in nonmyeloid malignancy, decrease neutropenia interval in BMT; mobilizing Peripheral Blood Stem Cells (PBSC)
Potential Benefits: Can decrease risk of infection, and help cancer patients continue their treatment without interruption.
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Precautions and common side effects chemocare
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Details rxlist.com
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Ann Oncol (2011):
Randomized comparison of pegfilgrastim day 4 versus day 2 for the prevention of chemotherapy-induced leukocytopenia http://bit.ly/X8SR0X
Patients of age 61–80 years with aggressive lymphoma were randomly assigned to receive 6 mg pegfilgrastim on day 2 or 4 of a 2-week chemotherapy regimen (R-CHOP-14).
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Impact of granulocyte colony-stimulating factor (CSF) and granulocyte-macrophage CSF in patients with malignant lymphoma: a systematic review. Br J Haematol. 2003 Aug;122(3):413-23. Review. PMID: 12877668
In conclusion, G-CSF/GM-CSF given during conventional chemotherapy in malignant lymphoma patients reduced the RR of neutropenia, febrile neutropenia and infection. However, there is no evidence that G-CSF/GM-CSF improved CR and OS in this clinical setting.
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ASCO 2003 Risk of Infection Doubles With Reduced (Filgrastim) Administration
- Optimal Usage of White Blood Cell Stimulator Important to Facilitating Dose-Dense Chemotherapy Regimens docguide.com
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Tips and Resources for giving subcutaneous Injections PAL
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GM-CSF
a growth factor, that helps to increase the number and function of white blood cells
Leukine®
(Sargramostim)
Stimulates progenitor cells to divide and differentiate in the granulocyte-macrophage pathways.
Related Abstracts
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Granulocyte-macrophage colony stimulating factor
(Leukine / Sargramostim)
Main purpose: Treatment of neutropenia (low white counts). Increases myeloid (blood cell) recovery. Treats delayed engraftment in bone marrow transplants (BMT). Helps mobilize peripheral blood stem cells. Treats neutropenia following BMT/PBSCT. Used experimentally to improve immune therapies, such as therapeutic cancer vaccines.
Potential Benefits: Can decrease risk of infection, and help cancer patients continue their treatment without interruption.
Common side effects MedlinePlus
"Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome." *
For a list of common side effects see:
* chemocare
Uncommon side effects
"You should always inform your health care provider if you experience any unusual symptoms."
For a list of many uncommon side effects see: *
Contraindications: rxlist.com Patients with:
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Excessive leukemic myeloid blasts in the bone marrow or
peripheral blood.
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Known hypersensitivity to GM-CSF, yeast-derived products or any component of the product
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About RxMed | Leukine | MedlinePlus | FDA | cancerbacup.org.uk
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Leukine (gm-csf) details berlex.com
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Granulocyte-Macrophage Colony-Stimulating Factor Receptor
Stage-Specific Expression and Function on Late B Cells bloodjournal.org pdf
By K.J. Till, J. Burthem, A. Lopez, and J.C. Cawley
Using sensitive triple-layer immunophenotypic techniques, we show here that both the (Y and @. chains of the GMR are expressed on hairy cells (HCs) and myelomatous plasma cells (PCs), but not on chronic lymphocytic leukemia (CLL) or prolymphocytic leukemia (PLL) lymphocytes. The receptor was demonstrable on normal PCs in tonsil, but not on either activated or resting tonsillar B cells or on circulating normal B lymphocytes.
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Impact of granulocyte colony-stimulating factor (CSF) and granulocyte-macrophage CSF in patients with malignant lymphoma: a systematic review. Br J Haematol. 2003 Aug;122(3):413-23. Review. PMID: 12877668
In conclusion, G-CSF/GM-CSF given during conventional chemotherapy in malignant lymphoma patients reduced the RR of neutropenia, febrile neutropenia and infection. However, there is no evidence that G-CSF/GM-CSF improved CR and OS in this clinical setting.
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Precautions and common side effects MedlinePlus
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Neutralizing antibodies to granulocyte-macrophage colony-stimulating factor, interleukin-1a and interferon-a, but not other cytokines in human immunoglobulin preparations blackwell-synergy.coml
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Immediate hypersensitivity to human recombinant granulocyte-macrophage colonystimulating factor associated with a positive prick skin test reaction - Renata J M Engler, MD* and Raymond B Weiss, MD PDF
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INF-alpha
Antiviral; modulates immunity
Benefit to survival?
"None of the other studies yet, as a single, show any survival benefit, but one had argued and the FDA did approve that if clinically aggressive indolent lymphomas, and that definition is a little bit hard to pin down, are treated with anthracycline- based regimens and then given interferon, there might be a prolongation of the disease-free interval or the failure-free survival, about a year and half. That needs to be managed and measured against the toxicity of those patients getting interferon for that period of time."
SOURCE: Current Therapies in the Treatment of Non-Hodgkin's Lymphoma: Chemotherapy, Richard I. Fisher, MD - Medscape
(free login req.)
Related Abstracts
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Interferon Alpha 2b
"Interferon is called so, because they interfere with viral RNA and protein synthesis; interferon probably induces enzymes that destroy viral RNA and other proteins. Human can produce at least 3 types of interferon (a, b, g); they are glycoproteins with a molecular weight of 20-25 kD". mfi.ku.dk
Main purpose: Adjuvant treatment for lymphoma
Use as consolidation of chemotherapy treatment (see below); Investigational use in combination with Rituxan.
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About Interferon cancerbacup.org.uk
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Interferon interacts with p53 to provide defense against cancer and viruses
oncolink
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Potential Benefits: Prolongation of the disease-free interval or the failure-free survival.
Treatment of lymphoma
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ASH 2003 [1437] Increased Angiogenesis Predicts Favorable Outcome in Patients with Follicular Lymphoma Treated with the Combination of Chemotherapy and Interferon-Alpha2b. Session Type: Poster Session 549-I abstractsview
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Role of interferon-alfa in NHL: still controversial? Oncology (Huntingt). 1999 Aug;13(8):1147-59; discussion 1159-60, 1163. Review. PMID: 10499247 PubMed
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Interferon in Oncological Practice: Review of Interferon Biology, Clinical Applications, and Toxicities Eric Jonasch, Frank G. Haluska Massachusetts General Hospital, Boston, Massachusetts, USA alphamedpress.org
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Interferon alpha & Follicular Non-Hodgkin's Lymphoma www.ncbi.nlm.nih.gov
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Interferons and hematology Rev Med Interne. 2002 Nov;23 Suppl 4:481s-488s. Review. French. PMID: 12481403 PubMed
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Regression of splenic lymphoma with villous lymphocytes after treatment of hepatitis C virus infection. N Engl J Med. 2002 Jul 11;347(2):89-94. PMID: 12110736 PubMed
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Meta-analysis to assess the efficacy of interferon-alpha in patients with follicular non-Hodgkin's lymphoma Medline
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Side effects
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Hyperactive stress response to interferon-alpha predicts development of depression oncolink
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Managing toxicities of - Interferon in Oncological Practice: Review of Interferon Biology, Clinical Applications, and Toxicities Eric Jonasch, Frank G. Haluska Massachusetts General Hospital, Boston, Massachusetts, USA alphamedpress.org
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PEG-Intron
Interferon - pegylated
Antiviral; modulates immunity
PEGASYS®
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Interferon -
Pegylated Interferon (Peginterferon alfa-2b)
Main purpose: Antiviral treatment
To help interferon last longer in the body scientists have attached a special strand (a PEG) to the interferon molecule. Once attached, the PEG helps protect the interferon from being destroyed by your immune system. This pegylated Interferon can last longer in the body, which might improve its efficacy and allow for dosing that can reduce side effects.
Potential Benefits: Use as consolidation of chemotherapy treatment (see below); Investigational use in combination with Rituxan.
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ASH 2002: Quality of Life is Significantly Better with Polyethylene Glycol Interferon than with the Standard Formulation PeerviewPress.com
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Product Information FDA | CenterWatch | hepwatch.com
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IL-11 (oprelvekin)
Neumega®
Related Abstracts
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IL-11 (oprelvekin)
"Neumega is a platelet growth factor that can help prevent extremely low platelet counts caused by chemotherapy. Treatment with Neumega may help cancer patients continue their treatment without interruption."
Main purpose: Treatment or prevention of low platelets.
"Neumega is a thrombopoietic growth factor that directly stimulates the proliferation of hematopoietic stem cells and megakaryocyte progenitor cells and induces megakaryocyte maturation resulting in increased platelet production."
Potential Benefits: Can decrease risk of bleeding, and help cancer patients continue their treatment without interruption.
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About FDA | MedlinePlus
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Randomized placebo-controlled study of recombinant human interleukin-11 to prevent chemotherapy-induced thrombocytopenia in patients with breast cancer receiving dose-intensive cyclophosphamide and doxorubicin. J Clin Oncol. 1997 Nov;15(11):3368-77. PMID: 9363868
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IL-12
Related Abstracts
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Interleukin-12
Main purpose: Experimental; immune modulator
Approved for the treatment of certain types of cancer.
Potential Benefits: Immune enhancement
Risks: "The major drawback of IL-2 therapy has been significant dose-related toxicity (see next page), which limits its use to patients who have excellent performance status, normal cardiac and pulmonary function, and no active infections." - Thomas Davis et al.
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About NCI
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Phase 1 study of interleukin-12 in combination with rituximab in patients with B-cell non-Hodgkin lymphoma. Blood. 2002 Jan 1;99(1):67-74. PMID: 11756154
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IL-2
(Aldesleukin)
Modulates immunity
Proleukin®
Related Abstracts
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Interleukin-2
Main purpose: Experimental; immune modulator.
Approved for the treatment of certain types of cancer.
Potential Benefits: Immune enhancement
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Product information MedlinePlus
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Possible side effects MedlinePlus
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ASH 2002: Proleukin® Plus Rituxan® may Reduce Recurrences Following Stem Cell Transplant in Non-Hodgkin’s Lymphoma CancerConsultants.com
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Pegfilgrastim
Stimulates production of neutrophils
Neulasta®
longer lasting version
Related Abstracts
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Pegfilgrastim (Neulasta)
Main purpose: Treatment or prevention of low white counts (neutropenia).
Prevention of severe chemotherapy-induced neutropenia - a severe drop in infection-fighting white blood cells (neutrophils). A common side effect of some kinds of chemotherapy
Potential Benefits: Can decrease risk of infection and help cancer patients continue their treatment without interruption.
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FDA: Neulasta® (Pegfilgrastim)
Information for Patients and Caregivers
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125031s0142lbl.pdf
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Pegfilgrastim on the Same Day Versus Next Day of Chemotherapy in Patients With
Breast Cancer, Non–Small-Cell Lung Cancer, Ovarian Cancer, and Non-Hodgkin's
Lymphoma: Results of Four Multicenter, Double-Blind, Randomized Phase II Studies
http://1.usa.gov/1hatNeO
A possible biologic explanation for the increase in FN observed in the same-day arms
may be that the initial stimulation of myeloid progenitor cells by pegfilgrastim
renders these cells more sensitive to the effects of cytotoxic chemotherapy.5,9 This
interpretation is consistent with median ANC curves (Fig 1), in which the measurable
difference in neutrophil kinetics seems to occur before the nadir. Furthermore,
although the magnitude varied by the degree of myelosuppression in each regimen, the
effect was the same in every study.
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Neulasta, full prescribing information:
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/125031s082lbl.pdf
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Product Information MedlinePlus
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Possible side effects MedlinePlus
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A Single Dose of Pegfilgrastim Is as Effective as Daily Filgrastim to Reduce the Duration of Severe, Chemotherapy-Induced Neutropenia. hemonctoday
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Single Injection Pegfilgrastim Supports Delivery of Dose-Dense Chemotherapy pslgroup.com/
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Pegfilgrastim (Neulasta) for chemo-induced neutropaenia docguide.com
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Erythropoietin
Stimulates production of erythrocytes --
red blood cells
Procrit®
Related Abstracts
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Erythropoietin or Epoetin
Main purpose: Treatment of anemia of patients on chemotherapy, which causes fatigue.
Stimulates red blood cell production. Triggers the division and differentiation of committed erythroid progenitors in the bone marrow.
Potential Benefits: Can reduce fatigue and help cancer patients continue their treatment without interruption.
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About MedlinePlus | noblood.com
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Possible side effects MedlinePLus
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Use of Epoetin in Patients With Cancer ASCO.org | Full text PDF
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Epoetin therapy is effective against anemia - Randomized, double-blind, placebo-controlled trial of recombinant human erythropoietin, epoetin Beta, in hematologic malignancies. J Clin Oncol. 2002 May 15;20(10):2486-94. PMID: 12011126
abstract
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Subcutaneous Injections
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Subcutaneous Injections
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Rituxan
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