FDA Approves Subcutaneous Keytruda Qlex

On Sept. 19, 2025, the US Food and Drug Administration (FDA) approved Merck’s Keytruda^® Qlex^™ (pembrolizumab and berahyaluronidase alfa-pmph) injection for subcutaneous (SC) use for the treatment of solid tumors in adults and pediatric patients aged 12 years and older, covering 38 cancer indications previously approved for intravenous (IV) Keytruda. However, unlike the IV formulation, Keytruda Qlex is not approved for hematologic malignancies such as classical Hodgkin lymphoma (cHL) or primary mediastinal large B-cell lymphoma (PMBCL). The fixed-dose combination leverages berahyaluronidase alfa, a human hyaluronidase variant that enhances dispersion and permeability, to enable rapid SC administration in as little as one minute every three weeks or two minutes every six weeks. The IV formulation is administered over 30 minutes. Approval was based on results from a phase III trial demonstrating pharmacokinetic comparability between SC and IV formulations, with overall response rates (ORR) of 45% and 42%, respectively, and no notable differences in progression-free survival (PFS) or overall survival (OS). The recommended dose is 395mg pembrolizumab and 4,800 units berahyaluronidase alfa-pmph every three weeks, or 790mg and 9,600 units every six weeks, administered by a healthcare professional until disease progression or unacceptable toxicity. Launch is expected by the end of September. Cost is expected to match that of the IV formulation. Full prescribing information is available here.

Subcutaneous Tremfya Approved for Ulcerative Colitis Induction

The FDA granted approval to Johnson & Johnson Innovative Medicine’s Tremfya^® (guselkumab) 400mg SC injection for induction treatment of moderately to severely active ulcerative colitis (UC) in adult patients on Sept. 19, 2025. Tremfya is a dual-acting monoclonal antibody that blocks interleukin-23 (IL-23) and binds to CD64, targeting key drivers of immune-mediated inflammation. This approval makes Tremfya the first IL-23 inhibitor to offer a fully SC regimen for both induction and maintenance, providing at-home self-administration from the start of therapy. Approval was based on the phase III ASTRO trial, which demonstrated statistically significant improvements in clinical remission (26% vs. 7%) and endoscopic improvement (36% vs. 12%) at week 12 compared to placebo. Results were consistent with prior IV induction data, and efficacy was sustained through week 24. The recommended SC induction dose is 400mg at weeks zero, four and eight, followed by maintenance dosing of 100mg every eight weeks or 200mg every four weeks. Updated prescribing information is available here.

Wellcovorin Back on the Market, Indication Expanded Expected

On Sept. 24, 2025, the FDA reinstated the approval of Wellcovorin^® (leucovorin calcium – GSK) tablets, originally approved in 1983 for rescue after high-dose methotrexate therapy, to diminish the toxicity of folic acid antagonists, and for the treatment of megaloblastic anemias due to folate deficiency. It was subsequently withdrawn in 2008 after the manufacturer stopped marketing the 5mg and 25mg tablets. The reinstatement follows a determination that the original withdrawal in 2008 was not due to safety or efficacy concerns. This follows the Sept. 22, 2025, FDA announcement of a collaborative effort with GSK to expand the labeling of Wellcovorin to include treatment of cerebral folate deficiency (CFD), a neurological condition associated with developmental delays and autistic features in pediatric and adult patients. Once approved, the updated prescribing information will be available in the Drugs@FDA drug database.

FDA Removes REMS Requirement for Caprelsa

The FDA has removed the Risk Evaluation and Mitigation Strategies (REMS) requirement for Genzyme Corporation’s Caprelsa^® (vandetanib), a 100mg oral tablet indicated for the treatment of symptomatic or progressive medullary thyroid cancer in patients who have unresectable locally advanced or metastatic disease on Sept. 25, 2025. Originally approved in 2011, Caprelsa’s REMS program was implemented due to concerns over QT prolongation and potential cardiac risks. However, after more than a decade of monitoring, no cases of torsades de pointes or unexplained sudden deaths have been reported among US patients, and clinical data show no concerning heart rhythm patterns. The FDA concluded that oncology specialists now have sufficient experience managing these risks, and standard clinical care practices have rendered the REMS program unnecessary. Caprelsa remains available with unchanged prescribing information, but providers are no longer required to undergo special certification or adhere to additional monitoring protocols. The updated prescribing information will be available in the Drugs@FDA drug database.

FDA Expands Evkeeza Approval to Include Children as Young as One Year of Age On Sept. 26, 2025, the FDA approved an expanded indication for Regeneron Pharmaceuticals’ Evkeeza^® (evinacumab-dgnb) to include children as young as one year of age with homozygous familial hypercholesterolemia (HoFH), as an adjunct to diet and lipid-lowering therapies. The drug, an angiopoietin-like 3 (ANGPTL3) inhibitor, was initially approved in 2021 for adults and adolescents aged 12 years and older, and its label was expanded in 2023 to include children aged five years to 11 years. Affecting around 1,300 patients in the US, HoFH occurs when both parents pass down mutations that severely impair lipid metabolism, leading to dangerously high cholesterol levels and early-onset cardiovascular disease. Given by monthly IV infusions, Evkeeza is dosed at 15mg/kg of body weight. For its revised prescribing information, look here.