Regulation - Marketing Authorisation

EC approves two new regimens of Merck’s KEYTRUDA for metastatic or unresectable recurrent HNSCC

Merck, known as MSD outside the US and Canada, announced that the European Commission has approved KEYTRUDA, Merck’s anti-PD-1 therapy, as monotherapy or in combination with platinum and 5-fluorouracil (5-FU) chemotherapy, for the first-line treatment of patients with metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) whose tumors express PD-L1 (combined positive score [CPS] ≥1).

Astellas’ gilteritinib secures EC approval to treat acute myeloid leukaemia

Astellas Pharma’s Xospata (gilteritinib) has secured approval from the European Commission (EC) as a monotherapy for the treatment of acute myeloid leukaemia (AML).

CHMP recommends Tecentriq, chemotherapy combo for NSCLC and ES-SCLC

Roche’s Tecentriq (atezolizumab) and chemotherapy combination has received positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for the treatment of two types of lung cancer.

EC approves ViiV Healthcare’s Dovato to treat HIV-1 infection

ViiV Healthcare has secured marketing authorisation from the European Commission (EC) for its Dovato (dolutegravir/lamivudine) to treat HIV-1 infection.

Sanofi, Regeneron bag EC approval for skin cancer drug Libtayo

Sanofi and Regeneron Pharmaceuticals have been given conditional approval by the European Commission (EC) for their fully-human monoclonal antibody Libtayo (cemiplimab) for the treatment of metastatic or locally advanced cutaneous squamous cell carcinoma (CSCC) in adults.

EC approves ZYNTEGLO gene therapy for transfusion-dependent β-thalassemia

bluebird bio has secured conditional marketing authorisation from the European Commission (EC) for its one-time gene therapy ZYNTEGLO (autologous CD34+ cells encoding βA-T87Q-globin gene) for the treatment of transfusion-dependent β-thalassemia (TDT).

Santhera seeks EMA approval for idebenone in Duchenne muscular dystrophy

Santhera Pharmaceuticals has filed a marketing authorization application (MAA) to the European Medicines Agency (EMA) for the approval of Puldysa (idebenone) for the treatment of respiratory dysfunction in patients with Duchenne muscular dystrophy (DMD).

Pfizer receives positive CHMP opinion for TALZENNA for patients with inherited BRCA-mutated locally advanced or metastatic breast cancer

Pfizer announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending TALZENNA (talazoparib), an oral poly (ADP-ribose) polymerase (PARP) inhibitor, be granted marketing authorization in the European Union (EU).

Lynparza secures European approval for type of advanced breast cancer

The European Commission has expanded the approval of AstraZeneca and MSD’s Lynparza (olaparib) to cover the treatment of a form of advanced breast cancer.