US and European Targeted Anti-Cancer Agent Approvals Announced

The US Food and Drug Administration has approved several new targeted anti-cancer agents, while the European Medicines Agency has extended indications for several therapies

medwireNews: The US Food and Drug Administration (FDA) has approved the use of dinutuximab for the treatment of children with high-risk neuroblastoma who have previously achieved at least a partial response to multimodal therapy.

The monoclonal antibody against the GD2 ganglioside is the first ever therapy specifically targeting the condition and will be given alongside interleukin-2, granulocyte–macrophage colony-stimulating factor (GM-CSF) and isotretinoin.

“[Dinutuximab] fulfills a critical need by providing a treatment option that prolongs survival in children with high-risk neuroblastoma”, commented Richard Pazdur, from the FDA Center for Drug Evaluation and Research in Silver Spring, Maryland, in a press release.

The priority review decision follows phase III trial results from the ANBL0032 study comparing the isotretinoin, interleukin-2 and GM-CSF regimen with or without dinutuximab in 226 children with newly diagnosed high-risk neuroblastoma.

Patients given the targeted therapy had significantly higher 3-year rates for event-free survival than those given the standard regimen, at 63% versus 46%, and overall survival, at 73% versus 58%.

The FDA has also recently given approval for several other targeted anti-cancer treatments.

This includes approval for the PDL-1 inhibitor nivolumab for the treatment of metastatic squamous non-small-cell lung cancer (NSCLC) in patients with disease progression after or during platinum-based chemotherapy.

Panobinostat was granted approval as a third-line treatment for multiple myeloma patients, to be given alongside bortezomib and dexamethasone, while lenvatinib was approved for patients with iodine-refractory differentiated thyroid cancer after local recurrence or metastatic progression.

Meanwhile, the European Medicines Agency’s Committee for Medicinal Products for Human Use published a positive opinion recommending conditional marketing authorisation for the use of ceritinib in patients with anaplastic lymphoma kinase-positive, advanced NSCLC who have previously received crizotinib .

Positive opinion for authorisation was also given for new indications for bevacizumab – for the treatment of persistent, recurrent or metastatic cervix carcinoma in combination with paclitaxel , and cisplatin or topotecan – and for panitumumab in patients with wild-type RAS metastatic colorectal cancer.

Pnitumumab should be given as a first-line treatment in combination with FOLFOX or FOLFIRI chemotherapy regimens.

The anti-epidermal growth factor receptor monoclonal antibody may also be given as a second-line treatment alongside FOLFIRI in patients who have previously been treated with fluoropyrimidine-based chemotherapy or as a single treatment after treatment with fluoropyrimidine-, oxaliplatin - and irinotecan -based regimens.


FDA website , visited last time 16 March 2015

EMA website , visited last time 16 March 2015

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