Regulatory Daily Summary: What Happened on October 16, 2026

EU committee recommends six medicines, including Rasonque and Foundayo

At its October meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use recommended six medicines for marketing authorization, bringing its 2026 total to 72.1 The recommendations include Rasonque for adults with metastatic pancreatic cancer after at least one prior treatment, Foundayo as an oral GLP-1 medicine for adult weight management and type 2 diabetes, and Yuviwel for children with achondroplasia.1

The committee also recommended Kizfizo for certain adults and children with brain tumors and issued positive opinions on two biosimilar medicines.1 These are committee recommendations, not final EU marketing authorizations. The European Commission will decide whether to authorize the medicines.14

In a Phase 3 study of 500 patients, median overall survival was 12.4 months with Rasonque and 6.7 months with chemotherapy. Median time without disease worsening was 7.2 months with Rasonque and 3.6 months with chemotherapy.4 The recommendation followed a phased review that began in early July and took less than 150 days, compared with up to 210 active days for a standard assessment.4

The committee upheld its negative recommendation for Yartemlea after reconsideration. It did not recommend extending Mylotarg to children with newly diagnosed acute myeloid leukemia, but agreed to add relevant study data to the product information.1 It recommended five extensions to existing medicines’ therapeutic indications and making Nyxoid, an emergency opioid-overdose treatment, available without a prescription.1

FDA extends Anktiva to papillary-only bladder cancer

The FDA added adults with BCG-unresponsive, high-grade papillary-only non-muscle invasive bladder cancer to Anktiva’s indication. The drug was already approved for patients with carcinoma in situ, with or without papillary tumors.25 The FDA based the expansion on efficacy results from patients with carcinoma in situ, citing clinical and laboratory similarities between the tumor types rather than separate efficacy results in the papillary-only group.25

In the supporting study, 62% of 77 patients with carcinoma in situ achieved a complete response. Of those responders, 40% maintained it for at least 24 months.25 The FDA acted nearly three months before the application’s January 6, 2027 target date. Anktiva was first approved in 2024 with BCG for BCG-unresponsive disease involving carcinoma in situ.25

Also worth knowing

• 

  Florida is considering ending school and daycare vaccine requirements for hepatitis B, chickenpox, Hib and pneumococcal conjugate vaccines while retaining seven others. Public comments are due by 5 p.m. October 19.6

• F

  HHS Secretary Robert F. Kennedy Jr. delegated authority to impose permissive exclusions from Medicare and Medicaid to the CMS administrator on October 14. The HHS Office of Inspector General retains its separate authority.7

• P

  The FDA cleared Roche’s Enspryng for thyroid eye disease.3

Also published

• CHMP backs Lilly's oral GLP-1 Foundayo for EU approval pharmaphorum
• ACT Brief: Who Sets Trial Endpoints, Human-Centered Trial Execution, and Bladder Cancer Approval Expansion Applied Clinical Trials
• The Bubble You Don’t Know You’re In: A Three-Part Series on The Medical Benefit Bubble Pharmaceutical Executive
• The Unique Considerations Mid-Sized Pharma Companies Face When Making MFN Deals Pharmaceutical Executive
• RevMed’s pancreatic cancer drug inches closer to EU approval after panel’s backing Pharmaceutical Technology
• Tigerlily Foundation joining conversation at PACE Bio.News
• RevMed nears EU okay for pancreatic cancer drug Rasonque pharmaphorum
• Judge Newman Suspension Matter Transferred to 11th Circuit Patent Docs
• The BioPharm Brief: New Approvals, Biosimilar Competition, and Deeper Remission BioPharm International
• ImmunityBio bags elusive label extension for Anktiva pharmaphorum