White Blood Cell Disorders
Udenyca will be supplied as 6mg/0.6mL preservative-free solution in prefilled syringes for subcutaneous injection.
The pediatric approval was supported by evidence from studies in adults with additional safety and pharmacokinetics data from a single-arm trial of 50 pediatric patients with solid tumors treated with Granix for chemotherapy-induced neutropenia.
The approval was based on data demonstrating that the biosimilar product and the reference product are highly similar, and that there are no clinically meaningful differences between the 2 agents.
"Periodic screening and monitoring of CBC while on treatment is crucial to monitor development of neutropenia which can be totally asymptomatic," the authors concluded.
A trial involving 93 eosinophilic esophagitis patients aged 11 to 40 years with dysphagia were randomly allocated to receive either budesonide oral suspension or placebo twice daily.
The Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for MYL-1401H (Mylan and Biocon), a proposed biosimilar candidate to Amgen's Neulasta (pegfilgrastim).
The BLA submission is supported by similarity data from analytical, pharmacokinetic, pharmacodynamic and immunogenicity studies comparing CHS-1701 to Neulasta.
The FDA has approved a supplemental Biologics License Application (sBLA) for Zarxio (filgrastim-sndz; Sandoz) to update the Warnings and Precautions section of the drug label.
The FDA has approved a Supplemental Biologics License Application (sBLA) for Neupogen (filgrastim; Amgen) to increase survival in patients acutely exposed to myelosuppressive doses of radiation (hemopoietic syndrome of acute radiation syndrome).
Amgen announced the launch of Neulasta (pegfilgrastim) Delivery Kit that allows the healthcare provider to initiate Neulasta on the same day as chemotherapy along with a full dose of Neulasta the following day.
Medications that are commonly linked to agranulocytosis development include clozapine, an atypical antipsychotic used in the treatment of schizophrenia, trimethoprim-sulfamethoxazole, an antibiotic, and methimazole, an agent for treating hyperthyroidism.
Janssen Biotech announced that the FDA has approved Sylvant (siltuximab) for the treatment of patients with multicentric Castleman's disease (MCD) who are HIV negative and HHV-8 negative.
Reducing the threshold of leukocytosis as a criterion for appendicitis to 8,000-9,000 white blood cells (WBCs) per µL reduces the rates of negative appendectomy.
For patients with anterior wall ST-segment elevated myocardial infarction (STEMI), elevated white blood cell count (WBCc) on presentation is associated with increased infarct size.
Janssen R&D submitted a Biologic License Application (BLA) to the FDA for siltuximab for the treatment of patients with multicentric Castleman disease (MCD) who are HIV-negative and human herpes virus-8 (HHV-8)-negative.
Oral monotherapy with moxifloxacin is as efficacious and safe as combination therapy with ciprofloxacin plus amoxicillin/clavulanic acid for treatment of fever in adult patients with cancer and neutropenia who are at low risk of complications.
Amgen announced the results from a Phase 3 study, Pegfilgrastim and Anti-VEGF Evaluation Study (PAVES) which evaluated Neulasta (pegfilgrastim) for the first-line treatment of locally-advanced or metastatic colorectal cancer.
New evidence-based guidelines have been compiled on the management of fever and and neutropenia (FN) in children with cancer and/or who are undergoing hematopoietic stem-cell transplantation
Teva announced that the FDA has approved Tbo-filgrastim (XM02 filgrastim injection solution), the first granulocyte colony-stimulating factor (G-CSF) to be approved in the United States in more than 10 years.