Guideline Central Blog

• Rivfloza (Novo Nordisk)
  • To lower urinary oxalate levels in children 9 years of age and older and adults with primary hyperoxaluria type 1 (PH1) and relatively preserved kidney function.

• Zoryve (Arcutis Biotherapeutics)Expanded Indication
  • Treatment of plaque psoriasis, including intertriginous areas, for children ages 6-11.

• Cosentyx (Novartis) New Formulation
  • Treatment of intermediate or high-risk myelofibrosis, including primary myelofibrosis or secondary myelofibrosis (post-polycythaemia vera and post-essential thrombocythaemia), in adults with anaemia.

• Braftovi + Mektovi (Pfizer)New Indication
  • For the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation, as detected by an FDA-approved test.

• Velsipity (Pfizer)
  • For adults with moderately to severely active ulcerative colitis (UC).

• Opdivo (Bristol Myers Squibb) Expanded Indication
  • For the adjuvant treatment of adult and pediatric patients 12 years and older with completely resected stage IIB or IIC melanoma.

• Keytruda (Merck) Expanded Indication
  • Treatment of patients with resectable (tumors ≥4 centimeters [cm] or node positive) non-small cell lung cancer (NSCLC) in combination with platinum-containing chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery.

• Zilbrysq (UCB Pharma)
  • For the treatment of generalized myasthenia gravis (gMG) in adult patients who are antiacetylcholine receptor (AChR) antibody positive.

• Xphozah (Ardelyx) 
  • To reduce serum phosphorus in adults with chronic kidney disease (CKD) on dialysis as add-on therapy in patients who have an inadequate response to phosphate binders or who are intolerant of any dose of phosphate binder therapy.

• Bimzelx (UCB Pharma)
  • Treatment of moderate to severe plaque psoriasis in adults.

• Qlosi (Orasis Pharmaceuticals) 
  • For the treatment of presbyopia in adults.

• Maxigesic IV (Hyloris Pharmaceuticals)
  • For the relief of mild to moderate pain and for the management of moderate to severe pain as an adjunct to opioid analgesics in adults, where an intravenous route of administration is considered clinically necessary.

• Penbraya (Pfizer) 
  • Prevention of the Five Most Common Serogroups Causing Meningococcal Disease in Adolescents.

• Cabtreo (Ortho Dermatologics)
  • For the topical treatment of acne vulgaris in patients twelve years of age and older.

• Rozlytrek (Genentech) Expanded Indication
  • For pediatric patients older than 1 month with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have progressed following treatment or have no satisfactory standard therapy.

• Voxzogo (BioMarin)
  • To increase linear growth in pediatric patients with achondroplasia with open epiphyses (growth plates).

• Zituvio (Zydus) 
  • As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

• Zymfentra (Celltrion USA) Biosimilar
  • For maintenance therapy in adults with moderately to severely active ulcerative colitis (UC) and Crohn’s disease (CD) following treatment with an infliximab product administered intravenously.

• Tibsovo (Servier Pharmaceuticals) 
  • For adults with isocitrate dehydrogenase (IDH)-1 mutated relapsed or refractory myelodysplastic syndromes (MDS).

• Agamree (Catalyst Pharmaceuticals)
  • Treatment of Duchenne Muscular Dystrophy.

• Vabysmo (Genentech) New Indication
  • For the treatment of macular edema following retinal vein occlusion (RVO).

• Omvoh (Eli Lilly)
  • For the treatment of moderately to severely active ulcerative colitis (UC) in adults.

• Loqtorzi (Coherus BioSciences) 
  • In combination with cisplatin and gemcitabine for the first-line treatment of adults with metastatic or recurrent locally advanced Nasopharyngeal Carcinoma (NPC), and as monotherapy for the treatment of adults with recurrent, unresectable, or metastatic NPC with disease progression on or after platinum-containing chemotherapy.

• Orencia (Bristol Myers Squibb)Expanded Indication
  • For treatment of psoriatic arthritis (PsA) in pediatric patients 2 years of age and older.

• Cosentyx (Novartis) New Indication
  • For adults with moderate-to-severe hidradenitis suppurativa (HS).

• Wezlana (Amgen) Biosimilar to Stelara
  • Biosimilar to Stelara – multiple indications, including plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis.

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