Your source for the latest industry trends and drug information news.
Volume 7 | Issue 10
May 15, 2025
Contributors:
Chief Authors: Rebecca Waite, PharmD
Contributing Authors: Salome Mawi, PharmD/MBA Candidate and Xintian Wu, PharmD/MBA Candidate
On April 25, 2025, the U.S. Food and Drug Administration (FDA) approved penpulimab-kcqx in combination with cisplatin or carboplatin and gemcitabine as first-line treatment for adults with recurrent or metastatic non-keratinizing nasopharyngeal carcinoma (nose and throat cancer- NPC). The medication was also approved as single drug regimen to treat adults with metastatic non-keratinizing NPC with disease progression on or after other chemotherapy drugs. Non-keratinizing NPC starts in the cells that line the nose and throat (epithelial cells) and it is often associated with the Epstein-Barr Virus (EBV).
The efficacy and safety of penpulimab-kcqx combination therapy were evaluated in a randomized, double-blind, phase 3 study of 291 patients with recurrent or metastatic NPC who had not started treatment with systemic chemotherapy. All patients received cisplatin or carboplatin and gemcitabine, and they were randomized to receive either penpulimab-kcqx or placebo following that regimen. Efficacy was evaluated after 12 months of follow-up. Median progression-free survival for the group treated with penpulimab-kcqx was 9.6 months compared to 7.0 months for those given placebo. The percentage of patients who were progression-free at 12 months for the two groups were 31% and 11%, respectively. The efficacy of single-agent penpulimab-kcqx was established in an open label study of 125 patients previously treated with a platinum-based chemotherapy and at least one other line of therapy. Common side effects are nausea, vomiting, underactive thyroid, constipation and decreased weight and appetite. The FDA granted penpulimab-kcqx Breakthrough Therapy, Orphan Drug and Fast Track designations.
On April 18, 2025, Amneal Pharmaceutical LLC announced a voluntary recall of two lots of ropivacaine hydrochloride 500mg/100mL infusion bags. Ropivacaine hydrochloride is an epidural anesthetic medication used during surgeries and for acute pain management. The recall was initiated due to potential polypropylene fibers, a type of plastic polymer, in the bags. Use of the affected product could cause these particulates to enter the area around the spinal cord and lead to inflammation and damage of the spinal cord or other serious adverse reactions.
The impacted product was distributed nationwide to wholesalers and distributors between the dates of 04/23/2024 to 11/8/2024. They are labeled as Lot AL240003 and AL240004 with an expiration date of January 2026. The manufacturer is arranging for the return of all recalled products. To date, Amneal Pharmaceuticals has received no reports of adverse events or injuries related to this recall. Adverse events should be reported to the FDA’s MedWatch Adverse Event Reporting Program.
On April 16, 2025, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) updated their recommendations for respiratory syncytial virus (RSV), meningitis, and chikungunya vaccines. ACIP recommended that at-risk adults 50 years and older receive a single dose of FDA-approved RSV vaccines, including Pfizer’s Abrysvo or GSK’s Arexvy, for the prevention of RSV infection. RSV is a respiratory virus that can lead to lung infections, pneumonia and hospitalization in infants or older adults. Individuals with weakened immune systems or chronic heart or lung disease are at the highest risk for severe RSV infections. The new recommendation from ACIP expands on the age range for RSV vaccination. Previously, the vaccine was recommended for adults over age 75 and at-risk adults 60-74 years.
ACIP panel also recommended the use of GSK’s new pentavalent meningococcal vaccine, Penmenvy, along with Pfizer’s Penbraya for healthy individuals ages 16–23 and for individuals ages 10 and older who are at increased risk of meningococcal disease. Individuals with HIV infection, a weakened immune system or who do not have a spleen are among those that have the highest risk of meningococcal disease.
Bavarian Nordic’s Vimkunya is FDA approved for prevention of disease caused by mosquito-borne chikungunya virus. ACIP recommends vaccination for travelers and laboratory scientists who work on the chikungunya virus. Valneva’s Ixchiq, an alternative chikungunya vaccine, is also recommended for travelers, but there is additional need for precaution for individuals aged 60 and older due to potential cardiac and neurological events. Due to this, on May 9, 2025, the FDA and CDC issued a recommendation that Ixchiq not be given to patients 60 years and older until a new risk-benefit assessment can be completed based on post-marketing safety reports.
New Drug: Imaavy™ (nipocalimab-aahu)
Intravenous injection approved for generalized myasthenia gravis (gMG), a chronic autoimmune neurologic disease that causes muscle weakness, in adult and pediatric patients 12 years and older who test positive for a specified antibody. [4/29/2025-Janssen Biotech, Inc]
Aptiom® (eslicarbazepine acetate)
Indication: Treatment of partial-onset seizures.
Dosage Form/Strength: 200mg, 400mg, 600mg and 800mg tablets
Average Wholesale Price (AWP): Generic = $1,455 | Brand = $1,616
