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New Clinical Guidelines & FDA Drug Approvals – March 2023

April 4, 2023 Guideline Central

Guideline Alerts March 2023 Banner Image
  • Penile Cancer
    • Society:American Society of Clinical Oncology (ASCO), European Association of Urology (EAU)
    • Published:March 10, 2023
FDA Drug Approvals March 2023 Banner Image
  • Verzenio (Eli Lilly) Expanded Indication
    • In combination with endocrine therapy for patients with hormone receptor (HR)–positive, HER2-negative, node-positive early breast cancer who are at high risk for recurrence.
  • Zavzpret (Pfizer)
    • Acute treatment of migraine with or without aura in adults.
  • Daybue (Acadia Pharmaceuticals) 
    • Treatment of Rett syndrome in adult and pediatric patients two years of age and older.
  • Tafinlar + Mekinist (Novartis)  
    • Treatment of pediatric patients 1 year of age and older with low-grade glioma (LGG) with a BRAF V600E mutation who require systemic therapy.
  • Illuccix (Telix Pharmaceuticals) Expanded Indication
    • For the selection of patients with metastatic prostate cancer, for whom Lu 177 PSMA-directed therapy is indicated.
  • Evkeeza (Regeneron) Expanded Indication
    • Adjunct to other lipid-lowering therapies to treat children aged 5 to 11 with homozygous familial hypercholesterolemia (HoFH).
  • Zynyz (Incyte)
    • Treatment of adults with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC).
  • Rezzayo (Cidara Therapeutics)
    • Treatment of candidemia and invasive candidiasis in adults with limited or no alternative treatment options.
  • Joenja (Pharming) 
    • Treatment of activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome (APDS) in adult and pediatric patients 12 years of age and older.
  • Hyrimoz (Sandoz) New Formulation
    • Multiple as biosimilar to Humira – new formulation approved.
  • Narcan (Emergent BioSolutions) Now Over-the-Counter
    • Emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression.

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