The FDA has announced a series of significant drug approvals targeting various cancer types and other medical conditions, with several breakthrough therapies receiving priority review designations and full approvals.
Bayer's Hyrnuo Targets HER2-Mutated NSCLC
Bayer Global received FDA approval for Hyrnuo (sevabertinib), an oral reversible small molecule tyrosine kinase inhibitor for treating locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) in adults. The approval follows both priority review and breakthrough drug designation, underscoring the significant unmet medical need in this patient population.
The approval was based on objective response rate and duration of response data from the ongoing Phase I/II SOHO-01 trial in patients with advanced NSCLC harboring a HER2-activating mutation, with disease progression after less than one systemic therapy for advanced disease. The FDA noted that continued approval for this indication may be contingent on verification and description of clinical benefit in a confirmatory trial.
Amgen's Imdelltra Receives Full Approval for Small Cell Lung Cancer
The FDA converted Amgen's Imdelltra (tarlatamab-dlle) from accelerated approval to full approval for treating adult patients diagnosed with extensive stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy. The decision was based on data from the global Phase III DeLLphi-304 study.
Notably, the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology have been updated to include Imdelltra as the only Category 1 preferred treatment option for adult patients with ES-SCLC with disease progression on or after platinum-based chemotherapy, highlighting its clinical significance.
AstraZeneca's Koselugo Approved for Neurofibromatosis
AstraZeneca received FDA approval for Koselugo (selumetinib), an oral, selective MEK inhibitor for treating adult patients with neurofibromatosis type 1 who have symptomatic, inoperable plexiform neurofibromas. The approval was based on positive results from the Phase III Komet trial, described as the only placebo-controlled global Phase III trial in this patient population. Trial results were presented at the 2025 American Society of Clinical Oncology Annual Meeting and published in The Lancet.
Additional Approvals Expand Treatment Options
Regeneron announced FDA approval of two indications for Eylea HD, including an 8mg injection for patients with macular edema following retinal vein occlusion, with up to every eight-week dosing and a monthly dosing option. The approval is based on data from the Phase III Quasar trial, which met its primary endpoint at 36 weeks, demonstrating that patients dosed with Eylea HD every 8 weeks achieved non-inferior visual acuity gains compared to those receiving Eylea dosed every four weeks.
Accord BioPharma received FDA approvals for two biosimilars: Osvytri, a biosimilar for Prolia, and Jubereq, a biosimilar to Xgeva, marking the company's fifth and sixth approved biosimilars. Osvytri was approved for treating postmenopausal women with osteoporosis at high risk for fracture and several other bone-related indications. Jubereq was approved to prevent skeletal-related events in patients with multiple myeloma and bone metastases from solid tumors, among other indications.
