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EMA Recommends Extension of Therapeutic Indications for Nivolumab and Ipilimumab

New indication concerns their combination in the first-line treatment of adult patients with unresectable malignant pleural mesothelioma
28 Apr 2021
Cancer Immunology and Immunotherapy;  Lung and other thoracic tumours

On 22 April 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 nivolumab (Opdivo) and ipilimumab (Yervoy). The marketing authorisation holder for these medicinal products is Bristol-Myers Squibb Pharma EEIG. 

The CHMP adopted a new indication in malignant pleural mesothelioma. 

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 (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 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. 

Malignant pleural mesothelioma  

Opdivo in combination with ipilimumab is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma. 

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 

Opdivo as monotherapy is indicated for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma after autologous stem cell transplant and treatment with brentuximab vedotin.

Squamous cell cancer of the head and neck

Opdivo as monotherapy is indicated for the treatment of recurrent or metastatic squamous cell cancer of the head and neck 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.

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 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. 

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. 

Malignant pleural mesothelioma 

Yervoy in combination with nivolumab is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma. 

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 report, and will be available in all official European Union languages after a decision on this change to the marketing authorisation has 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. 

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