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approvalsWatch: Oncology 180816

US FDA Approvals

Pembrolizumab
Pembrolizumab has been granted accelerated approval by the FDA for the treatment of recurrent or metastatic head and neck squamous cell carcinoma in patients who have experienced disease progression during or after platinum-based chemotherapy.

The programmed cell death 1 (PD-1) inhibitor status is conditional on the results of the ongoing KEYNOTE 040 clinical trial or another multicentre randomised study demonstrating superiority of pembrolizumab over standard therapy in this population.

Atezolizumab
Accelerated approval has been given for the programmed death ligand 1 (PD-L1) inhibitor for locally advanced or metastatic urothelial carcinoma after disease progression on or after platinum-based chemotherapy. Atezolizumab may also be given to patients who experience disease progression within 1 year of neoadjuvant or adjuvant platinum-containing chemotherapy.

Nivolumab
The anti-PD-1 monoclonal antibody nivolumab has received accelerated approval for the treatment of classical Hodgkin lymphoma in patients who have relapsed or experienced disease progression following autologous stem cell transplantation or post-transplantation treatment with brentuximab vedotin.

A new “Warning and Precaution” has been issued for the PD-1 inhibitor, however, for patients who have undergone transplantation after nivolumab. This has resulted in a requirement for further research and the recommendation that healthcare professionals should monitor such patients closely for transplant complications such as acute or hyperacute graft-versus-host disease and other immune-mediated reactions.

EMA Approvals

Cabozantinib
The EMA’s Committee for Medicinal Products for Human Use (CHMP) committee has adopted a positive opinion recommending marketing authorisation for the use of cabozantinib for advanced renal cell carcinoma (RCC).

The protein kinase inhibitor may be used in patients who have previously undergone treatment with a vascular endothelial growth factor (VEGF)-targeted agent.

Lenvantinib
The tyrosine kinase inhibitor lenvantinib has also been given a positive opinion for the treatment of RCC. The agent is indicated for patients with inoperable advanced or metastatic RCC after one course of VEGF-targeted therapy.

Irinotecan
A pegylated liposomal formulation of irinotecan has been granted a positive opinion for the treatment of metastatic pancreatic adenocarcinoma. The topoisomerase I inhibitor is approved for use in combination with 5-fluorouracil and leucovorin in adults who have experienced disease progression on gemcitabine-based chemotherapy.

Ibrutinib
A positive opinion has recommended a change in the indication for the Bruton’s tyrosine kinase inhibitor ibrutinib, authorising its use as a single agent for the treatment of relapsed or refractory mantle cell lymphoma and for select Waldenström’s macroglobulinaemia patients.

Ibrutinib may also be used for patients with chronic lymphocytic leukaemia, as a first-line monotherapy, and as second-line or later treatment singly or in combination with bendamustine and rituximab.

Crizotinib
A change in authorisation has also been recommended for the anaplastic lymphoma kinase (ALK) and ROS1 inhibitor, extending its use to include patients with ROS1-positive advanced non-small-cell lung cancer. The agent was previously approved for first-line and later treatment of ALK-positive disease.