Opdivo/Yervoy Combination Expanded in Rare Colorectal Cancer Type Use
On April 8, 2025, the US Food and Drug Administration (FDA) approved Bristol Myers Squibb’s Opdivo® (nivolumab) with Yervoy® (ipilimumab) as first-line therapy for patients 12 years of age and older with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (CRC). Previously, the cancer must have advanced despite treatment with a chemotherapy (chemo) regimen containing fluoropyrimidine, irinotecan or oxaliplatin. However, this indication expansion allows first-line use. The reduction in risk of disease progression or death was 38% in the combination group compared to Opdivo alone (p=0.0003). Approval was granted under Project Orbis, an FDA initiative under the Oncology Center of Excellence that speeds up approvals for drugs that may fill critical unmet needs. The FDA also converted accelerated approval to traditional approval for Yervoy for patients 12 years of age and older with MSI-H or dMMR metastatic CRC (mCRC) that has progressed following fluoropyrimidine, oxaliplatin and irinotecan. The updated prescribing information for Opdivo is here and Yervoy is here.
New Delivery System for Piperacillin and Tazobactam
The FDA approved piperacillin and tazobactam in B. Braun’s Duplex® Drug Delivery System on April 3, 2025. Piperacillin, a penicillin antibacterial and tazobactam, a beta-lactamase inhibitor, is a widely used injectable antibiotic used for susceptible bacterial infections. Administered intravenously (IV) by a health care provider in a hospital or clinic setting, this delivery system provides a ready-to-activate container that keeps the medications and diluents separate until the provider is ready to administer the medication. Duplex can be stored at room temperature. The cost and launch are not yet known. Here is the prescribing information.
Biocon Biosimilar for Avastin Approved
On April 10, 2025, the FDA approved Biocon Biologics’ Jobevne™ (bevacizumab-nwgd) injection, a new biosimilar for Genentech’s Avastin®. A vascular endothelial growth factor (VEGF) inhibitor, it is typically used in combination with chemotherapy (chemo) or other drugs to treat several different types of cancers. Given by IV infusions once every two weeks or every three weeks, doses vary according to the cancer being treated. Cost and launch information are not yet known. Four previously FDA-approved biosimilars for Avastin – Alymsys® (bevacizumab-maly – Amneal Pharmaceuticals), Mvasi® (bevacizumab-awwb – Amgen), Vegzelma® (bevacizumab-adcd – Celltrion) and Zirabev® (bevacizumab-bvzr – Pfizer Oncology) – are already sold in the United States. Prescribing information will be available on the Drugs@FDA drug database at www.fda.gov.
Vitrakbi Gets Full Approval
Bayer’s Vitrakvi® (larotrectinib) has been granted full approval by the FDA for the treatment of adult and pediatric patients with solid tumors that have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have no satisfactory alternative treatments or that have progressed following treatment on April 10, 2025. Accelerated approval was given in 2018 and was provided based on Vitrakvi resulting in an overall response rate (ORR) of 75%, with 22% of treated patients having a complete response (CR). Confirmatory trials showed an ORR of 60% with a CR of 24%. Prescribing information can be found here.
Next Generation Dexcom G7 15-Day Continuous Glucose Monitor Approved
On April 10, 2025, the FDA cleared Dexcom G7 15-Day Continuous Glucose Monitoring (CGM) System for people over the age of 18 years with diabetes. This is the next generation of the Dexcom G7 CGM, a small wearable sensor that sends accurate, real-time glucose readings to the Dexcom G7 app or receiver every five minutes. This marks the longest wearable available, as the original G7 CGM is approved for ten days. However, one study showed that up to 26% of sensors may not last the full 15.5 days. The cost is not yet known, and the launch is estimated for the second half of 2025.
Vyvgart Hytrulo Prefilled Syringe, Self Administration Formulation Approved
The FDA approved Vyvgart® Hytrulo (ergartigimod alfa and hyaluronidase-qvfc – Argenx) prefilled syringe for self-injection on April 10, 2025. Like the original formulation that requires a healthcare provider to reconstitute and deliver the subcutaneous (SC) doses, this formulation is also approved for the treatment of adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody-positive and adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP). The prefilled syringe uses ENHANZE®, a drug delivery technology by Halozyme, that allows for rapid delivery as a 20-to-30 second SC injection administered by the patient, caregiver or healthcare professional. Human factors studies showed that patients and caregivers safely and successfully administered the Vyvgart Hytrulo prefilled syringe. The launch is expected in the next two weeks and costs are expected to be comparable to the SC vial. Here is the prescribing information.
Soliris Biosimilars Launched
Two previously approved biosimilars to Soliris® (eculizumab – Alexion/AstraZeneca) are now available. Amgen’s Bkemv® (eculizumab-aeeb) launched on April 2, 2025, at the cost of $5,870.70 for a single-dose vial, about 10% below Soliris’ price. Bkemv also has interchangeability with the reference product. On April 7, 2025, Teva Pharmaceuticals and Samsung Bioepis announced that Epysqli® (eculizimab-aagh) is now available with a cost of $4,566.00 for a single dose, about 30% below the price of Soliris. These drugs treat the rare inherited conditions paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS) along with the treatment of gMG in adult patients who are AChR antibody positive. Here is the prescribing information for Bkemv and Epysqli.