Guideline Med Alerts & FDA Approvals - May 2024

Breyanzi (Bristol Myers Squibb)Expanded Indication

Treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have received at least two prior lines of systemic therapy, including a Bruton tyrosine kinase (BTK) inhibitor.

Retevmo (Eli Lilly) Expanded Indication

For Pediatric Patients Two Years and Older with RET-Altered Metastatic Thyroid Cancer or Solid Tumors.

Onyda XR (Tris Pharma)

Bkemv (Amgen)Biosimilar to Soliris

The treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis; and the treatment of patients with atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy.

Opuviz (Biogen) Biosimilar to Eylea

For parenteral nutrition providing a source of calories and essential fatty acids when oral or enteral nutrition is not possible, insufficient, or contraindicated.

Yesafili (Biocon Biologics) Biosimilar to Eylea

Imdelltra (Amgen)

For the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy.

Clinolipid (Baxter) Expanded Indication

For parenteral nutrition providing a source of calories and essential fatty acids when oral or enteral nutrition is not possible, insufficient, or contraindicated.

ColoSense (Geneoscopy) New Formulation

Multitarget stool RNA (mt-sRNA) test for colorectal cancer (CRC) screening in adults aged 45 or older who are at average risk for CRC.

Myhibbin (Azurity Pharmaceuticals) New Formulation

For the prophylaxis of organ rejection in adult and pediatric recipients 3 months of age and older of allogeneic kidney, heart, or liver transplants, in combination with other immunosuppressants.

Cyltezo (Boehringer Ingelheim) New Formulation

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