Oops, you're using an old version of your browser so some of the features on this page may not be displaying properly.

MINIMAL Requirements: Google Chrome 24+Mozilla Firefox 20+Internet Explorer 11Opera 15–18Apple Safari 7SeaMonkey 2.15-2.23

EMA Recommends Extension of Indications for Nivolumab and Ipilimumab

New indication concerns a combination of two drugs for the treatment of dMMR or MSI-H metastatic colorectal cancer
26 May 2021
Cancer Immunology and Immunotherapy;  Gastrointestinal cancers;  Personalised medicine

On 20 May 2021, the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions recommending changes to the terms of the marketing authorisations 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 as follows:

Mismatch repair deficient (dMMR) or microsatellite instability high (MSI-H) colorectal cancer (CRC)

Opdivo in combination with ipilimumab is indicated for the treatment of adult patients with dMMR or MSI-H metastatic CRC after prior fluoropyrimidine based combination chemotherapy.

Yervoy in combination with nivolumab is indicated for the treatment of adult patients with dMMR or MSI-H metastatic CRC after prior fluoropyrimidine based combination chemotherapy.

For information, the full indications for Opdivo will be as follows (new indication 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 (MPM)

Opdivo in combination with ipilimumab is indicated for the first line treatment of adult patients with unresectable MPM.

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.

dMMR or MSI-H CRC

Opdivo in combination with ipilimumab is indicated for the treatment of adult patients with dMMR or MSI-H metastatic CRC after prior fluoropyrimidine-based combination chemotherapy.

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 indication 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.

MPM

Yervoy in combination with nivolumab is indicated for the first line treatment of adult patients with unresectable MPM.

dMMR or MSI-H CRC

Yervoy in combination with nivolumab is indicated for the treatment of adult patients with dMMR or MSI-H metastatic CRC after prior fluoropyrimidine 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 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.

This site uses cookies. Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used.

For more detailed information on the cookies we use, please check our Privacy Policy.

Customise settings