Guideline Med Alerts & FDA Approvals – December 2024

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Focus
Medications

  • Tevimbra (BeiGene) New Indication
    • In combination with platinum and fluoropyrimidine-based chemotherapy, for the first-line treatment of unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma (G/GEJ) in adults whose tumors express PD-L1 (≥1).

  • Opdivo Qvantig (Bristol Myers Squibb) New Formulation
    • Multiple indications as a new formulation – in most previously approved adult, solid tumor Opdivo indications as monotherapy, monotherapy maintenance following completion of Opdivo plus Yervoy (ipilimumab) combination therapy, or in combination with chemotherapy or cabozantinib.

  • Gemtesa (Sumitomo)
    • For the treatment of men with overactive bladder (OAB) symptoms, such as urge urinary incontinence, urgency, and urinary frequency, who are receiving pharmacological therapy for benign prostatic hyperplasia (BPH).

  • Liraglutide Injection (Hikma) Generic of Victoza
    • To lower blood sugar in people aged 10 years or older with type 2 diabetes (T2D), as an adjunct to diet and exercise.

  • Imcivree (Rhythm Pharmaceuticals) Expanded Indication
    • To reduce excess body weight and maintain weight reduction long-term in patients 2 years of age and older with syndromic or monogenic obesity due to Bardet-Biedl syndrome (BBS) or genetically confirmed pro-opiomelanocortin (POMC), including proprotein convertase subtilisin/kexin type 1 (PCSK1), deficiency or leptin receptor (LEPR) deficiency.

  • Alhemo (Novo Nordisk)
    • To prevent or reduce the frequency of bleeding episodes in adult and pediatric patients 12 years of age and older with hemophilia A or B with inhibitors.

  • Trikafta (Vertex) Expanded Indication
    • For the treatment of people with cystic fibrosis (CF) ages 2 and older who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene or a mutation that is responsive to TRIKAFTA based on clinical and/or in vitro data.

  • Alyftrek (Vertex)
    • For the treatment of cystic fibrosis (CF) in people 6 years and older who have at least one F508del mutation or another mutation in the CFTR gene that is responsive to ALYFTREK.

  • Zepbound (Eli Lilly) New Indication
    • For adults with moderate-to-severe obstructive sleep apnea (OSA) and obesity.

  • Braftovi (Pfizer) New Indication
    • In combination with cetuximab (marketed as ERBITUX® ) and mFOLFOX6 (fluorouracil, leucovorin, and oxaliplatin) for the treatment of patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation, as detected by an FDA-approved test.

  • Symvess (Humacyte)
    • For use in adults requiring vascular conduit for extremity arterial injury when urgent revascularization is needed to avoid imminent limb loss and when autologous vein graft is not feasible.

  • Tryngolza (Ionis)
    • As an adjunct to diet to reduce triglycerides in adults with familial chylomicronemia syndrome (FCS).

  • Ryoncil (Mesoblast)
    • For steroid-refractory acute graft versus host disease (SR-aGVHD) in pediatric patients 2 months of age and older.

  • Ensacove (Xcovery Holdings)
    • For the treatment of adults with ALK-positive locally advanced or metastatic non-small cell lung cancer who have not previously received an ALK inhibitor.

  • Steqeyma (Celltrion) Biosimilar to Stelara
    • For the treatment of adults with active Crohn’s disease or ulcerative colitis and for both children aged ≥ 6 years and adults with moderate to severe plaque psoriasis or active psoriatic arthritis.

  • Vtama (Organon) New Indication
    • For the topical treatment of atopic dermatitis (AD) in adults and pediatric patients 2 years of age and older.

  • Nemluvio (Galderma) New Indication
    • For the treatment of patients 12 years and older with moderate-to-severe atopic dermatitis, in combination with topical corticosteroids (TCS) and/or calcineurin inhibitors (TCI) when the disease is not adequately controlled with topical prescription therapies.

  • Crenessity (Neurocrine Biosciences)
    • As an adjunctive treatment to glucocorticoid replacement to control androgens in adult and pediatric patients four years of age and older with classic congenital adrenal hyperplasia (CAH).

  • Unloxcyt (Checkpoint Therapeutics)
    • For the treatment of adults with metastatic cutaneous squamous cell carcinoma (“cSCC”) or locally advanced cSCC who are not candidates for curative surgery or curative radiation.

  • Imfinzi (AstraZeneca) Expanded Indication
    • For adults with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy.

  • Bizengri (Merus)
    • For the treatment of certain adults with non-small cell lung cancer (NSCLC) or pancreatic adenocarcinoma.

  • Yesintek (Biocon Biologics) Biosimilar to Stelara
    • For the treatment of Crohn’s disease, ulcerative colitis, plaque psoriasis, and psoriatic arthritis.

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