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EU Panel Recommends 4-Week Nivolumab Dosing Schedule in Adjuvant Melanoma

Gina Columbus @ginacolumbusonc
Published: Tuesday, Sep 24, 2019

Ralu Vlad, PharmD, development team lead, product design and delivery, Bristol-Myers Squibb

Ralu Vlad, PharmD

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended approval of nivolumab (Opdivo) at a flat dosing schedule of either 240 mg over 30 minutes every 2 weeks, or 480 mg infused over 60 minutes every 4 weeks, for the adjuvant treatment of patients with melanoma who have involvement of lymph nodes or metastatic disease who have undergone complete resection.1

  • Metastatic melanoma (monotherapy or monotherapy phase after combination treatment with ipilimumab)
  • Previously treated metastatic non–small cell lung cancer (NSCLC)
  • Advanced renal cell carcinoma (RCC) following prior antiangiogenic therapy
  • Previously treated locally advanced or metastatic urothelial carcinoma following disease progression during or after platinum-based chemotherapy
  • Classical Hodgkin lymphoma following relapse/progression after autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin, or three or more lines of systemic therapy that includes autologous HSCT
  • Recurrent/metastatic squamous cell carcinoma of the head and neck following platinum-based therapy
  • Hepatocellular carcinoma after prior sorafenib therapy
  • Adjuvant therapy for patients with completely resected melanoma with lymph node involvement or metastatic disease.
Research presented at the 2017 AACR Annual Meeting indicated that safety and efficacy would be similar between a nivolumab dosing schedule of 480 mg every 4 weeks compared with 3 mg/kg every 2 weeks.3 Using quantitative clinical pharmacology analyses and safety assessments, the investigators examined the predicted risk/benefit profile of the less frequent 480-mg regimen relative to the 3-mg/kg regimen.

V600–positive, a BRAF inhibitor.


  1. Bristol-Myers Squibb Receives Positive CHMP Opinion Recommending Approval of Opdivo (nivolumab) Four-Week Dosing Schedule for the Adjuvant Treatment of Adult Patients with Melanoma with Involvement of Lymph Nodes or Metastatic Disease who have Undergone Complete Resection. Bristol-Myers Squibb. Published September 24, 2019. Accessed September 24, 2019.
  2. Weber J, Mandala M, Del Vecchio M, et al. Adjuvant nivolumab versus ipilimumab in resected stage III or IV melanoma. N Engl J Med. 2017;377:1824-1835. doi: 10.1056/NEJMoa1709030.
  3. A model-based exposure-response (E-R) assessment of a nivolumab (NIVO) 4-weekly (Q4W) dosing schedule across multiple tumor types [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2017; 2017 Apr 1-5; Washington, DC. Philadelphia (PA): AACR; Cancer Res 2017;77(13 Suppl):Abstract CT101. doi:10.1158/1538-7445.AM2017-CT101.

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