Marketing Authorisation

BMS gets EC approval for Opdivo, Yervoy combo for treatment of metastatic NSCLC

Bristol Myers Squibb announced that the European Commission (EC) has approved Opdivo (nivolumab) plus Yervoy (ipilimumab) with two cycles of platinum-based chemotherapy for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have no sensitizing epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) translocation.

EC approves Zejula as first-line monotherapy maintenance treatment in advanced ovarian cancer

GlaxoSmithKline (GSK) announced the European Commission has approved Zejula (niraparib), an oral, once-daily poly (ADP-ribose) polymerase (PARP) inhibitor, as first-line monotherapy maintenance treatment for adult patients with advanced epithelial (FIGO Stages III and IV) high-grade ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response following platinum-based chemotherapy.

Imfinzi approved in the EU for the treatment of extensive-stage small cell lung cancer

AstraZeneca’s Imfinzi (durvalumab) has been approved in the European Union for the 1st-line treatment of adults with extensive-stage small cell lung cancer (ES-SCLC) in combination with a choice of chemotherapies, etoposide plus either carboplatin or cisplatin.

Celltrion secures EC approval for Remsima SC for five more indications

Celltrion Healthcare has secured approval from the European Commission (EC) for the subcutaneous (SC) formulation of autoimmune disease drug Remsima (infliximab, CT-P13) for the treatment of five more indications.

EC approves Reblozyl for transfusion-dependent anemia in myelodysplastic syndromes or beta thalassemia

Bristol Myers Squibb and Acceleron Pharma announced that the European Commission (EC) has approved Reblozyl (luspatercept) for the treatment of:

Janssen gets EC approval for subcutaneous use of daratumumab

Johnson & Johnson’s Janssen Pharmaceutical has secured approval from the European Commission for the subcutaneous formulation of Darzalex (daratumumab) for the treatment of multiple myeloma in adult patients.

Sanofi secures EC approval for Sarclisa for third-line multiple myeloma

Sanofi has secured approval from the European Commission (EC) for Sarclisa (isatuximab) in combination with pomalidomide and dexamethasone (pom-dex) for the treatment of relapsed and refractory multiple myeloma (MM) in adult patients.

Bristol Myers Squibb receives EC approval for Zeposia in adults with RRMS with active disease

Bristol Myers Squibb announced that the European Commission (EC) has approved Zeposia (ozanimod) for the treatment of adult patients with relapsing remitting multiple sclerosis (RRMS) with active disease as defined by clinical or imaging features.

EC approves subcutaneous formulation of Entyvio as maintenance therapy in ulcerative colitis or Crohn’s disease

Takeda Pharmaceutical announced that the European Commission has granted a Marketing Authorization for the subcutaneous (SC) formulation of Entyvio (vedolizumab), a gut-selective biologic for use as maintenance therapy in adults with moderately to severely active ulcerative colitis (UC) or Crohn’s disease (CD).