Generic Promacta Tablet and Oral Suspension Launched

The US Food and Drug Administration (FDA) approved Hetero Lab’s eltrombopag olamine tablets on Jan. 17, 2025, and Annora Pharma’s eltrombopag olamine oral suspension on April 18, 2024, reference to Novartis’ Promacta^. Promacta, a thrombopoietin receptor, treats thrombocytopenia and severe aplastic anemia. It generated about $3.8 billion in 2024 US sales. Eltrombopag olamine will be available as 12.5mg, 25mg, 50mg, 75mg tablets and 12.5mg and 25mg oral suspension. They became available on May 13, 2025, through Camber. Prescribing information can be found on the Drugs@FDA drug database at www.fda.gov.

New, Rare Cancer Indication for Welireg

Merck’s Welireg^ (belzutifan) was granted FDA approval for patients 12 years and older with locally advanced, unresectable, or metastatic pheochromocytoma or paraganglioma (PPGL) on May 14, 2025. Welireg inhibits hypoxia-inducible factor-2 alpha (HIF-2α) and is the first oral therapy for PPGL, a rare, potentially fatal, neuroendocrine tumor. In the US, there are about 500-1,600 new cases per year. Objective response rate was 26% and median duration of response was 20.4 months in the trial supporting approval. Welireg was first FDA approved in 2021 to treat patients who have renal cell carcinoma (RCC), and other cancers associated with a rare genetic disease, von Hippel-Lindau (VHL) syndrome, which causes cancerous and non-cancerous tumors in various parts of the body. The recommended dose of Welireg in adults is 120mg (three tablets) once a day while in pediatric patients 12 years and older dosing is weight based.  The recommended dose in children weighing at least 40kg is 120mg once daily; the dose in children weighing less than 40kg is 80mg once daily. A boxed warning cautions that taking Welireg can damage an unborn baby, so women should not take it if they are pregnant. Because using it can disrupt hormonal forms of contraception, women of childbearing age also should use a reliable non-hormonal contraceptive during treatment. Other common side effects include blood abnormalities, electrolyte imbalances and elevated liver enzymes. Updated prescribing information is here.

Brekiya Approved for Migraines

On May 15, 2025, the FDA approved Brekiya^ [dihydroergotamine mesylate (DHE) – Amneal Pharmaceuticals] injection for the acute treatment of migraine with or without aura and the acute treatment of cluster headaches in adults. Although various forms of DHE have been used for decades to treat migraines, injectable forms are not always convenient to use. This is the first self-administered, ready-to-use autoinjector that does not require refrigeration or priming of the device. The recommended dose is 1mg administered subcutaneously (SC) in the thigh and may be repeated as needed in one-hour intervals to a total maximum dose of 3mg in 24 hours, and not to exceed 6mg total in one week. A boxed warning on all DHE products explains that using it while taking some other drugs, such as some antibiotics, antifungals and antivirals, may increase the risk of interrupted blood flow in the brain or the hands and feet. It is expected to be available in the second half of 2025. Here is the prescribing information.

Anal Cancer Indications for Zynyz

The FDA approved Incyte’s Zynyz^ (retifanlimab-dlwr) for two new indications on May 15, 2025. The humanized monoclonal antibody targeting programmed death receptor-1 (PD-1) was approved in combination with carboplatin and paclitaxel (platinum-based chemotherapy) for the first-line treatment of adult patients with inoperable locally recurrent or metastatic squamous cell carcinoma of the anal canal (SCAC) and as a single agent for the treatment of adult patients with locally recurrent or with metastatic SCAC with disease progression on or intolerance to platinum-based chemotherapy. SCAC is a rare disease, but its incidence is increasing. It is associated with human papillomavirus (HPV) and HIV infections and accounts for almost 3% of digestive system cancers. Patients with metastatic SCAC have a poor five-year survival and this is the first treatment approved for those who have progressed after first-line chemotherapy. Zynyz is also approved for the treatment of adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC). The recommended dose for all indications is 500mg administered as an intravenous (IV) infusion every four weeks. Updated prescribing information is here.