On 17 September 2020, 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 product nivolumab (Opdivo).
The marketing authorisation holder for this medicinal product is Bristol-Myers Squibb Pharma EEIG.
The CHMP adopted an extension to the existing indication for 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.
For information, the full indications for Opdivo will be 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.
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.
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.
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.
On 17 September 2020, the CHMP adopted also a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product ipilimumab (Yervoy).
The marketing authorisation holder for this medicinal product is Bristol-Myers Squibb Pharma EEIG.
The CHMP adopted a new indication as follows:
NSCLC
YERVOY in combination with nivolumab 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.
For information, the full indications for Yervoy will be as follows (new text in bold):
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 progression-free survival and overall survival 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.
NSCLC
YERVOY in combination with nivolumab 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.
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 decision on these changes to the marketing authorisation 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 opinion.