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Filgrastim is FDA approved to Decrease the incidence of infection‚ as manifested by febrile neutropenia‚ in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe neutropenia with feverReduce the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of patients with acute myeloid leukemia (AML)Reduce the duration of neutropenia and neutropenia-related clinical sequelae‚ e.g.‚ febrile neutropenia, in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation (BMT)Mobilize autologous hematopoietic progenitor cells into the peripheral blood for collection by leukapheresisReduce the incidence and duration of sequelae of severe neutropenia (e.g.‚ fever‚ infections‚ oropharyngeal ulcers) in symptomatic patients with congenital neutropenia‚ cyclic neutropenia‚ or idiopathic neutropeniaIncrease survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome)
Neupogen® Filgrastim G-CSF Zarxio™ * Filgrastim-sndz* Nivestym™ * Filgrastim-aafi* Releuko* Filgrastim-ayow*
Gemtuzumab ozogamicin is approved for the treatment ofNewly-diagnosed CD33-positive acute myeloid leukemia (AML) in adults and pediatric patients 1 month and older Relapsed or refractory CD33-positive AML in adults and pediatric patients 2 years and older (1.2).
Mylotarg® Gemtuzumab ozogamicin
Gilteritinib is a indicated for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation as detected by an FDA-approved test.
Xospata® Gilteritinib
Glasdegib is indicated, in combination with low-dose cytarabine, for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adult patients who are ≥75 years old or who have comorbidities that preclude use of intensive induction chemotherapy.Limitation of Use: Glasdegib has not been studied in patients with the comorbidities of severe renal impairment or moderate-to-severe hepatic impairment.
Daurismo® Glasdegib
Glofitamab-gxbm is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified (DLBCL, NOS) or large B-cell lymphoma (LBCL) arising from follicular lymphoma, after two or more lines of systemic therapy.
Glofitamab-gxbm Columvi™
Granulocyte Colony-Stimulating and Granulocyte-Macrophage Colony-Stimulating Growth Factors
Filgrastim, pegfilgrastim and sargramostim are synthetic versions of substances naturally produced in your body. They are FDA approved to prevent or reduce the risk of infection for patients with nonmyeloid malignancies who are being treated with anti-inflammatory drugs that inhibit blood cell production and are associated with severely low counts of certain white blood cells (neutropenia). Colony-stimulating growth factors may also be used to help the marrow recover after stem cell transplantation. Sargramostim is FDA approved to increase survival in adult and pediatric patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome, or H-ARS).
Neupogen® G-CSF Granulocyte Colony-Stimulating and Granulocyte-Macrophage Colony-Stimulating Growth Factors
Imatinib mesylate is FDA approved to treatNewly diagnosed adult and pediatric patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phasePatients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in blast crisis (BC), accelerated phase (AP), or in chronic phase (CP) after failure of interferon-alpha therapyAdult patients with relapsed or refractory Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL)Pediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) in combination with chemotherapyAdult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with PDGFR (platelet-derived growth factor receptor) gene re-arrangements as determined with an FDA-approved testAdult patients with hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukemia (CEL) who have the FIP1L1-PDGFRα fusion kinase (mutational analysis or FISH demonstration of CHIC2 allele deletion) and for patients with HES and/or CEL who are FIP1L1- PDGFRα fusion kinase negative or unknown.
Gleevec® Imatinib mesylate
Obinutuzumab is FDA-approved In combination with chlorambucil chemotherapy for the treatment of people with previously untreated chronic lymphocytic leukemia (CLL).In combination with bendamustine followed by obinutuzumab monotherapy for the treatment of patients with follicular lymphoma (FL) who relapsed after, or are refractory to, a rituximab-containing regimen.In combination with chemotherapy followed by obinutuzumab monotherapy in patients achieving at least a partial remission, for the treatment of adult patients with previously untreated stage II bulky, III or IV follicular lymphoma.
Gazyva® Obinutuzumab
Pegfilgrastim is FDA approved toDecrease 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.Increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Subsyndrome of Acute Radiation Syndrome).Limitations of Use: Pegfilgrastim is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation
Neulasta® Pegfilgrastim G-CSF Fulphila™ * Pegfilgrastim-jmdb* Udenyca™ * Pegfilgrastim-cbqv* Ziextenzo™ * Pegfilgrastim-bmez * Nyvepria Pegfilgrastim-apgf* Fylnetra* Pegfilgrastim-pbbk* Stimufend®* Pegfilgrastim-fpgk*
Sargramostim is FDA approvedTo shorten time to neutrophil recovery and to reduce the incidence of severe and life-threatening infections and infections resulting in death following induction chemotherapy in adult patients 55 years and older with acute myeloid leukemia (AML).For the mobilization of hematopoietic progenitor cells into peripheral blood for collection by leukapheresis and autologous transplantation in adult patients. For the acceleration of myeloid reconstitution following autologous bone marrow or peripheral blood progenitor cell transplantation in adult and pediatric patients 2 years of age and older.For the acceleration of myeloid reconstitution following allogeneic bone marrow transplantation in adult and pediatric patients 2 years of age and older.For treatment of delayed neutrophil recovery or graft failure after autologous or allogeneic bone marrow transplantation in adult and pediatric patients 2 years of age and older.To increase survival in adult and pediatric patients from birth to 17 years of age acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome [H-ARS]).
Leukine ® GM-CSF Sargramostim