EMA-recommendations-primeoncology_2017

EMA Recommends Approval of Six New Indications for Anticancer Agents in July

On 20 July 2017, the European Medicines Agency (EMA) released positive opinions for six new indications for anticancer therapies. These include new treatments for follicular lymphoma (FL), gastroenteropancreatic neuroendocrine tumors (GEP NETs), Merkel cell carcinoma, urothelial carcinoma, and non-small cell lung cancer (NSCLC).

  • The EMA recommended extending the approval of a CD20-directed antibody obinutuzumab (Gazyvaro®, Roche) for treatment of FL to include use in combination with chemotherapy, followed by obinutuzumab maintenance, in previously untreated patients. This recommendation is based on results from the randomized phase III GALLIUM study, in which obinutuzumab/chemotherapy combination followed by obinutuzumab in the front-line setting reduced the risk of disease progression or death by 34% compared to rituximab/chemotherapy followed by rituximab in patients with FL. Prior to this recommendation, the indication of obinutuzumab in treatment of FL was limited to use in combination with bendamustine in patients who had progressed during or up to six months following treatment with rituximab or a rituximab-containing regimen.
  • The radiopharmaceutical lutetium (Lu-177) oxodotreotide (Lutathera®, Advanced Accelerator Applications) was recommended for treatment of unresectable or metastatic well-differentiated, somatostatin receptor–positive GEP NETs. The positive opinion was adopted based on results of the pivotal randomized phase III NETTER-1 trial. In this trial, treatment with Lu-177 was associated with significant and clinically meaningful risk reduction of 79% in disease progression or death compared to high-dose octreotide LAR in patients with advanced, progressive, somatostatin receptor–positive midgut NETs.
  • Avelumab (Bavencio®, Merck Serono Europe), a programmed death–receptor 1 ligand (PD-L1) inhibitor, received a positive opinion for the treatment of adult patients with metastatic Merkel cell carcinoma. Merkel cell carcinoma is a rare and difficult to treat disease, and avelumab is the first new treatment option approved for this indication. The FDA granted accelerated approval to avelumab for treatment of this disease for both adult and pediatric patients (≥12 years old) in May 2017 based on the JAVELIN Merkel 200 trial.
  • The indication of the PD-1 inhibitor pembrolizumab (Keytruda®, Merck Sharp & Dohme Limited) was expanded to include use in both newly diagnosed and relapsed metastatic urothelial cancer. Use in the first-line is limited to patients who are not eligible for cisplatin-containing chemotherapy, while second-line use includes all patients who have received prior platinum-containing chemotherapy. These approvals are based on results from the Keynote-052 and Keynote-045 studies. In the Keynote-045 study, treatment with pembrolizumab (regardless of PD-L1 expression) resulted in an almost three-month improvement in overall survival (OS) compared to chemotherapy. Pembrolizumab was previously approved by the FDA for the same indications.
  • The EMA also granted a positive opinion for the approval of the PD-L1 inhibitor atezolizumab (Tecentriq®, Roche) for both metastatic urothelial carcinoma and metastatic NSCLC. In urothelial carcinoma, atezolizumab will be available for use as first-line treatment in cisplatin-ineligible patients and as second-line treatment in patients previously treated with platinum-based chemotherapy. In NSCLC, recommended approval is for patients who have progressed on chemotherapy. Patients with targetable mutations must have received prior targeted therapy for these mutations. Atezolizumab is already approved in the United States for both urothelial cancer and NSCLC.

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