On October 13th 2016, the EMA CHMP gave a positive opinion for granting a change to the terms of the marketing authorization such as to add a new indication for the drug Opdivo® (nivolumab) from Bristol-Myers Squibb. Opdivo® already had approved indications in the treatment of Melanoma, Renal Cell Carcinoma and Non-Small Cell Lung Cancer, but has now been given a positive opinion for the treatment of Classical Hodgkin’s Lymphoma (cHL).
The new indication for Opdivo® is in instances where adults with Relapsed/Refractory (R/R) cHL have both already received Autologous Stem Cell Transplant (ASCT) and have been treated with brentuximab vedotin. This new indication from the EMA CHMP is similar to the new indication approved by the FDA for Opdivo® in May 2016, which was granted for use in patients where cHL has progressed or relapsed post-ASCT and brentuximb vedotin treatment.
On 13 October 2016, the 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 Opdivo. The marketing authorisation holder for this medicinal product is Bristol-Myers Squibb Pharma EEIG.
The CHMP adopted a new indication as follows:
'Opdivo is indicated for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL) after autologous stem cell transplant (ASCT) and treatment with brentuximab vedotin.'
For information, the full indications for Opdivo will be as follows:
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) for the combination of nivolumab with ipilimumab is established only in patients with low tumour PD-L1 expression (see sections 4.4 and 5.1).
Non-Small Cell Lung Cancer (NSCLC)
Opdivo is indicated for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) after prior chemotherapy in adults.
Renal Cell Carcinoma (RCC)
Opdivo as monotherapy is indicated for the treatment of advanced renal cell carcinoma after prior therapy in adults.
Classical Hodgkin lymphoma (cHL)
Opdivo is indicated for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL) after autologous stem cell transplant (ASCT) and treatment with brentuximab vedotin.'
Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published in the revised European public assessment report (EPAR), 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.
- European Medicines Agency, Committee for Medicinal Products for Human Use (CHMP) Opinion, Opdivo, 13th October 2016.
- United States Food & Drug Administration, May 17th 2016. Nivolumab (Opdivo) for Hodgkin Lymphoma.