Guideline Med Alerts & FDA Approvals - August 2024

ACAM2000 (Emergent BioSolutions)Expanded Indication
- For prevention of mpox disease in individuals determined to be at high risk for mpox infection.
Pavblu (Amgen)Biosimilar to Eylea
- For the treatment of patients with neovascular (wet) age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME), and diabetic retinopathy (DR).
Comirnaty (2024-2025) (Pfizer) New Formulation
- For active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 years of age and older.

Spikevax (2024-2025) (Moderna) New Formulation
- For active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 years of age and older.

Lazcluze (Janssen)
- In combination with amivantamab-vmjw (Rybrevant, Janssen Biotech, Inc.) for the first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test.

NexoBrid (Vericel)Expanded Indication
- For eschar removal in pediatric patients with deep partial-thickness and/or full-thickness thermal burns.

Imfinzi (AstraZeneca) New Indication
- With platinum-containing chemotherapy as neoadjuvant treatment, followed by single-agent durvalumab as adjuvant treatment after surgery for adults with resectable (tumors ≥ 4 cm and/or node positive) non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements.

Niktimvo (Incyte)
- For the treatment of chronic graft-versus-host disease (cGVHD) after failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing at least 40 kg.

Yorvipath (Ascendis Pharma)
- For the treatment of hypoparathyroidism in adults. Yorvipath is a prodrug of parathyroid hormone (PTH[1-34]).

Furoscix (scPharmaceuticals) Expanded Indication
- For the treatment of congestion due to fluid overload in adults with chronic heart failure.

Enzeevu (Sandoz)Biosimilar to Eylea
- To improve and maintain visual acuity in patients with neovascular age-related macular degeneration.

Neffy (ARS Pharmaceuticals)
- For the treatment of Type I Allergic Reactions, including anaphylaxis, in adults and children who weigh ≥30 kg (66 lbs.).

Lymphir (Citius Pharmaceuticals)
- For the treatment of r/r cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy.

Crexont (Amneal Pharmaceuticals)
- For the treatment of Parkinson’s disease.

Zurnai (Purdue Pharma)
- Auto-Injector for the Emergency Treatment of Known or Suspected Opioid Overdose.

Darzalex Faspro (Janssen) Expanded Indication
- In combination with bortezomib, lenalidomide, and dexamethasone (D-VRd) for induction and consolidation in patients with newly diagnosed multiple myeloma (MM) who are eligible for an autologous stem cell transplant (ASCT).

Fabhalta (Novartis) New Indication
- The reduction of proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression, generally a urine protein-to-creatinine ratio (UPCR) ≥1.5 g/g.

Voranigo (Servier Pharmaceuticals)
- For the treatment of certain isocitrate dehydrogenase (IDH)–mutant diffuse gliomas.

Tecelra (Adaptimmune)
- For the treatment of adults with unresectable or metastatic synovial sarcoma who have received prior chemotherapy, are HLA antigen(s) A*02:01P, -A*02:02P, -A*02:03P, or -A*02:06P positive, and whose tumor expresses the MAGE-A4 antigen as determined by FDA authorized companion diagnostic devices.

Jemperli (GlaxoSmithKline)New Indication
- In conjunction with carboplatin and paclitaxel, followed by single-agent dostarlimab-gxly, for adults with primary advanced or recurrent endometrial cancer.

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