Showing results for:
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*
Filgrastim-sndz is FDA approved as a biosimilar to US-licensed Neupogen® for the five indications for which Neupogen is approved:Patients with cancer receiving myelosuppressive chemotherapy;Patients with acute myeloid leukemia receiving induction or consolidation chemotherapy;Patients with cancer undergoing bone marrow transplantation;Patients undergoing autologous peripheral blood progenitor cell collection and therapy; andPatients with severe chronic neutropenia.
Zarxio® Filgrastim-sndz
Ibritumomab tiuxetan is FDA approved to treat people who have relapsed or refractory, low-grade or follicular non-Hodgkin lymphoma (NHL), including patients with follicular NHL that did not respond to therapy with rituximab. It is also FDA approved to treat patients with previously untreated follicular NHL who achieve a partial or complete response to first-line chemotherapy. This drug is a monoclonal antibody with an attached radioisotope to deliver radiation therapy to the lymphoma cells.
Zevalin® Ibritumomab tiuxetan
Idelalisib is FDA approved to treat patients with relapsed chronic lymphocytic leukemia (CLL), in combination with rituximab, in patients for whom rituximab alone would be considered appropriate therapy due to other co-morbidities.
Zydelig® Idelalisib
Loncastuximab tesirine-lpyl is indicated for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, DLBCL arising from low grade lymphoma, and high-grade B-cell lymphoma. This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
Zynlonta™ Loncastuximab tesirine-lpyl
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*
Vemurafenib (Zelboraf®) is FDA approved for the treatment of patients with Erdheim-Chester Disease (ECD) with BRAF V600 mutation.
Zelboraf® Vemurafenib
Vorinostat is FDA approved to treat cutaneous T-cell lymphoma (CTCL) in patients whose CTCL gets worse, does not go away or comes back after treatment with two systemic therapies.
Zolinza® Vorinostat
Zanubrutinib is indicated for the treatment of adult patients with:Mantle cell lymphoma (MCL) who have received at least one prior therapy.This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.Waldenström’s macroglobulinemia (WM)Relapsed or refractory marginal zone lymphoma (MZL) who have received at least one anti–CD20-based regimen. This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Relapsed or refractory follicular lymphoma (FL), in combination with obinutuzumab, after two or more lines of systemic therapy.This indication is approved under accelerated approval based on response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
Brukinsa® Zanubrutinib
Zoledronic acid is FDA approved to treat hypercalcemia (high levels of blood calcium) that may occur in patients with some types of cancer, including myeloma. It is also FDA approved along with chemotherapy to treat bone damage caused by myeloma or by cancer that began in another part of the body but has spread to the bones.
Zometa® Zoledronic acid