Bavencio Receives Full FDA Approval

In 2017, the U.S. Food and Drug Administration (FDA) awarded Bavencio^® (avelumab – EMD Serono) injection Accelerated Approval as monotherapy for treating metastatic Merkel cell carcinoma (MCC) for patients who are at least 12 years old. Recently, positive results from post-marketing clinical studies have reinforced Bavencio’s effectiveness and safety in treating MCC, so the indication now has been given full FDA approval. Its two other indications are for maintaining or treating patients’ urothelial carcinoma (UCC) and, in combination with Inlyta^® (axitinib – Pfizer) tablets, for initial therapy of advanced renal cell carcinoma (RCC). Bavencio is a human programmed death receptor-1 (PD-1)-blocking antibody that increases the immune system’s ability to destroy cancer cells. Its recommended dosing for all indications is 800mg given as a 60-minute intravenous (IV) infusion once every two weeks. Updated prescribing information is here.

Pediatric Indications Extended for Mekinist and Tafinlar

The Accelerated Approval of Novartis Tafinlar® (dabrafenib) and Mekinist® (trametinib) for treating solid tumors that have BRAF V600E mutations, that have worsened despite previous treatment, and that have no other therapy options, has been extended to children with at least one year old. The lower age limit had been six years old before the FDA action on Aug. 31, 2023. Ongoing clinical studies are required to provide support for the indication, which is not yet verified for full approval. Used together, the two drugs, which both are kinase inhibitors, also have full indications to treat BRAF V600-mutated advanced melanoma, non-small cell lung cancer (NSCLC), and anaplastic thyroid cancers. Additionally, they are FDA-approved to treat children as young as one year old who need systemic therapy for low-grade gliomas that test positive for BRAF V600E mutations. For both drugs, pediatric doses depend on the child’s weight — with Tafinlar administered twice daily and Mekinist once daily. All doses should be given one hour or more before or two hours or more after food. In addition to 50mg and 75mg capsules, Tafinlar is available as 10mg tablets that are dissolved in water for administration. Mekinist is dispensed in bottles containing powder that has 0.05mg/mL once it is reconstituted, as well as in 0.5mg and 2mg tablets. Revised prescribing information is here for Tafinlar and here for Mekinist.

Recall
On Aug. 30, 2023, Marlex Pharmaceuticals recalled one lot each of digoxin tablets 0.125mg and 0.25mg because the labels were switched. As a result, patients may have taken doses that were either one-half or twice what they were prescribed. Doses that are too high could result in blurred vision, confusion, dizziness, and memory loss; lower-than-prescribed doses may not manage heart rate adequately. For more information, the FDA’s notice is here.