Your source for the latest industry trends and drug information news.
Volume 7 | Issue 11
June 1, 2025
Contributors:
Chief Authors: Rebecca Waite, PharmD
Contributing Authors: Salome Mawi, PharmD/MBA Candidate, Xintian Wu, PharmD/MBA Candidate, and Jessica Lin PharmD/MBA Candidate
On May 15, 2025, the U.S. Food and Drug Administration (FDA) approved Zynyz® (retifanlimab-dlwr) to be used in combination with carboplatin and paclitaxel for the first-line treatment of adults with inoperable locally recurrent or metastatic squamous cell carcinoma of the anal canal (SCAC). The medication was also approved as a single drug regimen for the treatment of adults with locally recurrent or metastatic SCAC with disease progression on or intolerance to platinum-based chemotherapy drugs. SCAC is the most common type of anal cancer. It starts in the thin and flat cells (squamous cells) that line the anal canal and is commonly linked to certain types of human papilloma virus (HPV).
The efficacy and safety of Zynyz® with carboplatin and paclitaxel were studied in a randomized, double-blind clinical trial involving 308 patients with inoperable locally recurrent or metastatic SCAC who had not received any chemotherapy treatment in the past. All patients received carboplatin on Day 1 and paclitaxel on Days 1, 8 and 15 for 6 cycles, and were then randomized to receive either Zynyz® or placebo. Median progression-free survival for the group that received Zynyz® was 9.3 months compared to 7.4 months for the placebo group. The efficacy of Zynyz® as a single agent was studied in an open-label trial of 94 patients with locally recurrent or disease progression on or intolerance to previous platinum-based chemotherapy. Side effects include infection, pain, blood clots in the lungs, diarrhea, and vomiting. Zynyz® was granted orphan drug and fast-track designation and priority review by the FDA.
On May 16, 2025, the FDA issued a warning about severe itching that can occur after stopping long-term use of oral allergy medicines containing cetirizine or levocetirizine (Zyrtec®, Xyzal®, OTC store brand generics, etc.). These antihistamine medications are used to treat seasonal and long-term allergies, as well as chronic hives, and are available both by prescription and over the counter (OTC). The itching has been reported to occur within a few days of stopping cetirizine or levocetirizine following daily use for at least a few months. Although reported incidents were rare, some were serious and required medical attention.
To increase awareness, the FDA will now require the labeling of these products to include a warning about the risk of severe itching when stopping long-term use of cetirizine or levocetirizine, along with a statement indicating the symptoms may improve with restarting the medication. The labeling changes are required for both prescription and OTC products containing cetirizine or levocetirizine. Patients should contact their health care provider if they experience severe itching after stopping these medications, and these reactions should be reported to the FDA’s MedWatch Adverse Event Reporting Program.
On May 12, 2025, President Trump signed an executive order (EO) directing the Administration to pursue most- favored-nation drug pricing, a policy aimed at lowering U.S. prescription drug cost by aligning them with the lowest prices paid by other developed countries. By requiring manufacturers to lower their drug prices in the U.S. and shift the cost to other developed countries, the EO seeks to ensure the burden of the cost for pharmaceutical research and development does not fall disproportionately to the U.S. The EO also directs the Secretary of Health and Human Services to establish direct-to-consumer purchasing programs with pharmaceutical manufacturers and negotiate voluntary price reductions. The EO also describes potential actions that may be taken if significant progress is not made toward most-favored-nation pricing with pharmaceutical manufacturers. Some of the potential actions include antitrust enforcement by federal agencies, identifying instances to allow importation of prescription drugs from developed nations with low-cost medications, and potential restrictions on the export of drugs or precursor chemicals. Further details on the implementation of the EO are expected in the coming months.
New Drug: Avmapki™ Fakzynja™ Co-Pack (avutometinib/ defactinib)
Oral capsule and tablet combination approved for the treatment of a certain type of ovarian cancer, called KRAS-mutated recurrent low-grade serous ovarian cancer (LGSOC), in adult patients who have received prior systemic therapy.
Jynarque® (tolvaptan)
Indication: To slow the decline of kidney function in adults with rapidly progressing autosomal dominant polycystic kidney disease, a genetic condition where fluid-filled cysts grow in the kidneys.
Dosage Form/Strength: 15mg, 30mg, 45mg, 60mg, and 90mg tablets
Average Wholesale Price (AWP): Generic = $23,271 | Brand = $25,885
