EMA Recommends Approval for Pembrolizumab, Nivolumab, Dinutuximab

Pembrolizumab, nivolumab and dinutuximab receive recommendations for marketing authorisation in Europe

medwireNews: The European Medicines Agency (EMA) has recommended that marketing authorisation be given for three molecular agents targeting advanced melanoma, squamous non-small-cell lung cancer (NSCLC) and high-risk neuroblastoma.

The EMA’s Committee for Medicinal Products for Human Use (CHMP) gave a positive opinion in favour of authorisation for the anti-programmed cell death (PD)-1 monoclonal antibody pembrolizumab for the treatment of adult patients with unresectable or metastatic melanoma.

The agent was shown in clinical trials to offer overall and progression-free survival benefits to such patients compared with the cytotoxic T lymphocyte-associated protein 4 inhibitor ipilimumab , and when compared with chemotherapy in patients who had previously received ipilimumab.

The CHMP stated in a press release that their review of over 1000 patients indicated pembrolizumab’s safety profile “appears manageable” and that monitoring of the agent’s safety and efficacy will be ongoing.

The CHMP also adopted a positive opinion recommending marketing authorisation be given for the anti-PD-1 monoclonal antibody nivolumab for patients with locally advanced or metastatic squamous NSCLC who have previously received chemotherapy.

Phase III trial results indicated that nivolumab offers this patient population a significant overall survival benefit compared with docetaxel , and this was supported by findings from an uncontrolled study of patients who had been given at least two prior chemotherapy regimens.

Finally, the EMA’s CHMP recommended that dinutuximab, given alongside granulocyte-macrophage colony-stimulating factor, interleukin-2 and isotretinoin, be approved for patients aged 1 to 17 years with high-risk neuroblastoma.

Clinical trial results for this regimen indicated a higher progression-free survival rate compared with isotretinoin alone.

The infusion of the monoclonal chimeric antibody against the ganglioside GD2, which is highly expressed on neuroblastoma cells, is indicated for patients who achieved at least a partial response to induction chemotherapy and underwent myeloablative therapy and autologous stem cell transplantation.

Reports of irritation and severe nerve pain associated with dinutuximab means that pain relief should also be given before and during treatment, the CHMP statement says.


European Medicines Agency: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 18-21 May 2015; Page accessed last time 27 May 2015.

medwireNews (www.medwireNews.com ) is an independent medical news service provided by Springer Healthcare Limited. © Springer Healthcare Ltd; 2015