On 25 February 2021, the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal products cabozantinib (Cabometyx) and nivolumab (Opdivo).
The marketing authorisation holder for Cabometyx is Ipsen Pharma. The marketing authorisation holder for Opdivo is Bristol-Myers Squibb Pharma EEIG.
The CHMP adopted an extension to an existing indication for Cabometyx as follows (new text in bold):
Renal Cell Carcinoma (RCC)
Cabometyx is indicated as monotherapy for the treatment of advanced RCC:
- in treatment-naïve adults with intermediate or poor risk,
- in adults following prior vascular endothelial growth factor targeted therapy.
Cabometyx, in combination with nivolumab, is indicated for the first-line treatment of advanced RCC in adults.
Hepatocellular Carcinoma (HCC)
Cabometyx is indicated as monotherapy for the treatment of HCC in adults who have previously been treated with sorafenib.
The CHMP adopted an extension to an existing indication for Opdivo as follows (new text in bold):
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 and overall survival 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 in combination with ipilimumab and 2 cycles of platinum-based chemotherapy is indicated for the first-line treatment of metastatic NSCLC in adults whose tumours have no sensitising EGFR mutation or ALK translocation.
Opdivo as monotherapy is indicated for the treatment of locally advanced or metastatic NSCLC after prior chemotherapy in adults.
Renal cell carcinoma (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.
Opdivo in combination with cabozantinib is indicated for the first-line treatment of adult patients with 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.
Oesophageal squamous cell carcinoma
Opdivo as monotherapy is indicated for the treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma after prior fluoropyrimidine- and platinum-based combination chemotherapy.
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 the changes to the marketing authorisations have been granted by the European Commission.
Summaries of positive opinion are published without prejudice to the Commission decision, which will normally be issued 67 days from adoption of the opinions.
