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
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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
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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)
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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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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.
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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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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.)
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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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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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IL-11 (oprelvekin)
Neumega®
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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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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
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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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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®
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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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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
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Pegfilgrastim
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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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®
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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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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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