The U.S. Food and Drug Administration lifted a partial clinical hold on Bristol-Myers Squibb Co.'s phase 3 study to evalute Opdivo in combination with other drugs in certain blood cancer patients.
Bristol-Myers said the study, named CheckMate -602, is evaluating the addition of Opdivo to pomalidomide and dexamethasone in patients with multiple myeloma who are not responsive to treatment or whose disease has returned following treatment.
Multiple myeloma is an incurable blood cancer which forms in plasma cells, a type of white blood cell responsible for making antibodies. It is characterized by a recurring pattern of remission and relapse.
The company said the decision to lift the hold follows consultation with the FDA and agreement on amendments to the study protocol.
In September 2017, the FDA placed partial clinical hold as a precaution on three trials evaluating Opdivo-based combinations in relapsed or refractory multiple myeloma after risks were found in trials studying pembrolizumab in patients with multiple myeloma.
Bristol-Myers Squibb's phase 3 study is the last of the three trials to have its partial clinical hold lifted after the agency removed partial holds on two other trials in December 2017.
