Approvals

Roche gets CHMP approval recommendation of combo therapy for lymphoma

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended the approval of Roche’s Polivy (polatuzumab vedotin) and MabThera (rituximab) plus cyclophosphamide, doxorubicin, and prednisone (R-CHP) combination to treat lymphoma.

FDA declines to approve Eli Lilly, Innovent’s lung cancer treatment

The US Food and Drug Administration (FDA) has declined to approve Eli Lilly and Company and Innovent Biologics’ investigational medicine sintilimab injection in combination with pemetrexed and platinum chemotherapy to treat nonsquamous non-small cell lung cancer (NSCLC).

US FDA approves Merck’s anti-PD-1 therapy for endometrial carcinoma patients

The US Food and Drug Administration (FDA) has approved Merck’s anti-PD-1 therapy, Keytruda, to treat advanced endometrial carcinoma patients.

FDA extends review period for Incyte’s sNDA for ruxolitinib cream

The US Food and Drug Administration (FDA) has extended the review period for Incyte’s supplemental New Drug Application (sNDA) for ruxolitinib cream (Opzelura) to treat vitiligo.

AstraZeneca, Merck get FDA approval for Lynparza to treat breast cancer

AstraZeneca and Merck have obtained the US Food and Drug Administration approval for Lynparza (olaparib) to treat early-stage breast cancer.

Janssen submits application to EMA for mantle cell lymphoma therapy approval

The Janssen Pharmaceutical Companies of Johnson & Johnson has submitted a Type II variation application seeking approval for the new indication of Imbruvica (ibrutinib) plus bendamustine and rituximab (BR) combination from the European Medicines Agency (EMA).

EMA accepts GlaxoSmithKline’s MAA for chronic kidney disease therapy

The European Medicines Agency (EMA) has accepted GlaxoSmithKline’s marketing authorisation application (MAA) for daprodustat to treat anaemia of chronic kidney disease (CKD).

FDA declines to grant approval for Gilead Sciences’ HIV treatment

The US Food and Drug Administration (FDA) has declined to grant approval for Gilead Sciences’ investigational therapy lenacapavir for HIV.

AbbVie files sNDA to FDA for chronic graft versus host disease therapy

AbbVie has submitted a supplemental new drug application (sNDA) for Imbruvica (ibrutinib) to the US Food and Drug Administration (FDA) to treat chronic graft versus host disease (cGVHD) in paediatric and adolescent patients.