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Nivolumab Dosing Schedules Approved for Europe

A 4-week dosing schedule for nivolumab (Opdivo) has been approved by the European Commission for the treatment of patients with advanced melanoma and previously treated renal cell carcinoma (RCC), Bristol-Myers Squibb (BMS), the manufacturer of the PD-1 inhibitor, has announced.

The commission specifically approved a 4-week dosing regimen with 480 mg of nivolumab for these indications. Additionally, the commission approved replacing weight-based dosing with 240 mg every 2 weeks for the 6 nivolumab monotherapy indications approved in the European Union—melanoma, non–small cell lung cancer (NSCLC), RCC, classical Hodgkin lymphoma, head and neck squamous cell carcinoma (HNSCC), and urothelial carcinoma.

nivolumab“This approval marks a significant achievement in our longstanding commitment to providing patients and healthcare providers with more flexible and convenient treatment options,” Fouad Namouni, MD, head of development, Oncology, BMS, said in a statement. “Bristol Myers-Squibb is dedicated to addressing the unique needs of patients, and with this approval, we will now be able to offer a range of dosing options for an immuno-oncology medicine approved in the European Union.”

In March 2018, the FDA approved a supplemental biologics license application adding the 4-week dosing schedule for nivolumab across several of the PD-1 inhibitor’s indications.

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.

Read the full article here on targetedOncology.com