ESMO: European Society for Medical Oncology

1. EMA Recommends Granting a Marketing Authorisation for Generic Lenalidomide

   Lenalidomide Accord is intended for the treatment of multiple myeloma

2. EMA Refuses a Change to the Marketing Authorisations for Nivolumab and Ipilimumab

   Intended change concerned both medicines in combination for first-line treatment of advanced renal cell carcinoma

3. FDA Approves Mogamulizumab-kpkc for Mycosis Fungoides or Sézary Syndrome

   Approval of CCR4 directed monoclonal antibody is based on results from the Study 0761-010

4. EMA Recommends Granting a Marketing Authorisation for Generic Gefitinib

   Gefitinib Mylan is intended for the treatment of patients with locally advanced or metastatic NSCLC with activating mutations of EGFR

5. EMA Recommends Extension of Indications for Daratumumab

   New indication concerns combination with bortezomib, melphalan and prednisone for the treatment of adults with newly diagnosed multiple myeloma