BMS week: two label updates, new luspatercept CKD trial, pulmonary fibrosis study registered

The week's items cover two FDA label approvals and three newly registered or recruiting studies tied to Bristol-Myers Squibb.

• The FDA approved a labeling supplement for REVLIMID (lenalidomide), listed as SUPPL 70 with a submission status date of 2026-07-22 and approval documents dated 2026-07-24.
• The FDA also approved a labeling supplement for INREBIC (fedratinib hydrochloride), SUPPL 11, with a submission status date of 2026-07-20 and label document dated 2026-07-27.
• A Phase 2 study of luspatercept for anemia due to chronic kidney disease, led by Memorial Sloan Kettering Cancer Center with Bristol-Myers Squibb as collaborator, is recruiting; the researchers are testing whether luspatercept works to improve hemoglobin levels in people with anemia caused by chronic kidney disease.¹ The trial plans to enroll 30 participants¹.
• Bristol-Myers Squibb registered an observational study in Japan, "UPWARD," that is not yet recruiting and will explore how adults in Japan with pulmonary fibrosis decide whether to continue or discontinue antifibrotic therapy after experiencing antifibrotic therapy-related adverse events.² The study covers Pulmonary Fibrosis, Idiopathic Pulmonary Fibrosis, and Progressive Pulmonary Fibrosis² and plans to enroll 40 participants.
• Bristol-Myers Squibb also registered an observational study, active but not recruiting, examining how immunotherapy is used in people in Europe and Canada with non-small cell lung cancer who undergo surgery, looking at participant characteristics, treatments received before and after surgery, and outcomes such as survival.³ The study plans to enroll 300 participants³ across Europe and Canada.