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New Nivolumab Dosing Schedules Approved in Europe

Published: Wednesday, Apr 25, 2018

Fouad Namouni, MD
Fouad Namouni, MD
The European Commission has approved a 4-week dosing schedule for nivolumab (Opdivo) for the treatment of patients with advanced melanoma and previously treated renal cell carcinoma (RCC), according to Bristol-Myers Squibb (BMS), the manufacturer of the PD-1 inhibitor. 

Physicians can now prescribe the new dosing schedule of 480 mg of nivolumab infused every 30 minutes every 4 weeks for these approved indications:
  • Metastatic melanoma (monotherapy or monotherapy phase after combination treatment with ipilimumab [Yervoy])
  • Previously treated metastatic NSCLC
  • Advanced 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 HNSCC 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.
Physicians now have the option of using either the new 4-week dosing schedule or the previously approved schedule of 240 mg every 2 weeks, now available in a new 240 mg vial.

Among patients with melanoma, NSCLC, or RCC, there was a <1% difference in the predicted probability of achieving a response. The predicted 1- and 2-year survival probabilities were also similar among patients with these tumor types receiving either of the 2 doses, with differences ranging between 0% to 4.6% at year 1, and 1.9% to 6.9% at year 2.
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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