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European Panel Backs New Nivolumab Dosing Schedules

Jason Harris
Published: Monday, Mar 26, 2018

Fouad Namouni, MD
Fouad Namouni, MD
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended adding the option of a 4-week dosing schedule to the label for nivolumab (Opdivo) for the treatment of patients with advanced melanoma and previously treated renal cell carcinoma (RCC).1 

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.

The FDA first approved nivolumab as a single agent for advanced melanoma in December 2014, as a treatment for patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600–positive, a BRAF inhibitor.

References

  1. Bristol-Myers Squibb Receives Positive CHMP Opinion Recommending Approval of Opdivo Four-Week Dosing Schedule for Advanced Melanoma and Previously Treated Renal Cell Carcinoma. Bristol-Myers Squibb. https://bit.ly/2pGtRkQ. Accessed March 26, 2018.
  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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