Paid

Clinical Roundup

Subcutaneous Opdivo shows noninferiority vs. intravenous Opdivo in advanced or metastatic RCC

The phase III CheckMate -67T trial, evaluating the subcutaneous formulation of Opdivo (nivolumab) co-formulated with Halozyme’s proprietary recombinant human hyaluronidase (rHuPH20) (herein referred to as “subcutaneous nivolumab”) compared to intravenous Opdivo in patients with advanced or metastatic clear cell renal cell carcinoma (ccRCC) who have received prior systemic therapy, demonstrated noninferiority for the co-primary endpoints of Cavgd28 (time-averaged Opdivo serum concentration over 28 days) and Cminss (trough serum concentration at steady state) compared to IV Opdivo. 
Drugs & Targets

Abecma receives positive CHMP opinion in MM indication

The Committee for Medicinal Products for Human Use of the European Medicines Agency has recommended marketing authorization approval of Abecma (idecabtagene vicleucel; ide-cel) for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody. 
Drugs & Targets

European Commission authorizes Omjjara in anemia indication

The European Commission has granted marketing authorization for Omjjara (momelotinib), a once-a-day, oral JAK1/JAK2 and activin A receptor type 1 (ACVR1) inhibitor.  Omjjara is the first authorized medicine in the EU for disease-related splenomegaly (enlarged spleen) or symptoms in adult patients with moderate to severe anemia who have primary myelofibrosis, post polycythaemia vera myelofibrosis or... […]