On 15 November 2018, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for the use of nivolumab (Opdivo) and ipilimumab (Yervoy) in combination to treat renal cell carcinoma (RCC). After re-examining its negative opinion adopted in July 2018, the CHMP adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal products Opdivo and Yervoy.
The marketing authorisation holder for both medicinal products is Bristol-Myers Squibb Pharma EEIG.
The CHMP adopted an extension to an existing indication for Opdivo as follows:
Opdivo in combination with ipilimumab is indicated for the first-line treatment of adult patients with intermediate/poor-risk advanced RCC.
The CHMP adopted a new indication for Yervoy as follows:
Yervoy in combination with nivolumab is indicated for the first-line treatment of adult patients with intermediate/poor-risk advanced RCC.
For information, the full indications for Opdivo will be as follows:
Melanoma
Opdivo as monotherapy or in combination with ipilimumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults. Relative to nivolumab monotherapy, an increase in progression-free survival (PFS) and overall survival (OS) for the combination of nivolumab with ipilimumab is established only in patients with low tumour PD-L1 expression.
Adjuvant treatment of melanoma
Opdivo as monotherapy is indicated for the adjuvant treatment of adults with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection.
Non-small cell lung cancer (NSCLC)
Opdivo as monotherapy is indicated for the treatment of locally advanced or metastatic NSCLC after prior chemotherapy in adults.
RCC
Opdivo as monotherapy is indicated for the treatment of advanced RCC after prior therapy in adults.
Opdivo in combination with ipilimumab is indicated for the first-line treatment of adult patients with intermediate/poor-risk advanced RCC.
Classical Hodgkin lymphoma (cHL)
Opdivo as monotherapy is indicated for the treatment of adult patients with relapsed or refractory cHL after autologous stem cell transplant and treatment with brentuximab vedotin.
Squamous cell cancer of the head and neck (SCCHN)
Opdivo as monotherapy is indicated for the treatment of recurrent or metastatic SCCHN in adults progressing on or after platinum-based therapy.
Urothelial carcinoma
Opdivo as monotherapy is indicated for the treatment of locally advanced unresectable or metastatic urothelial carcinoma in adults after failure of prior platinum-containing therapy.
For information, the full indications for Yervoy will be as follows:
Melanoma
Yervoy as monotherapy is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults, and adolescents 12 years of age and older.
Yervoy in combination with nivolumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults. Relative to nivolumab monotherapy, an increase in PFS and OS for the combination of nivolumab with ipilimumab is established only in patients with low tumour PD-L1 expression.
RCC
Yervoy in combination with nivolumab is indicated for the first-line treatment of adult patients with intermediate/poor-risk advanced RCC.
Detailed recommendations for the use of these products will be described in the updated summaries of product characteristics, which will be published in the revised European public assessment reports and will be available in all official European Union languages after a decision on these changes to the marketing authorisations has been granted by the European Commission.
Summaries of positive opinions are published without prejudice to the Commission decision, which will normally be issued 67 days from adoption of the opinions.