Minimal Residual Disease 'Coming Soon' As An Approval Endpoint, Celgene Says
Celgene's ASH briefing notes 'unprecedented' MRD-negative data in Phase I study in multiple myeloma development program for CAR-T therapy bb2121; firm sees potential opportunity for the marker to pave way for approval in earlier-line settings of the disease.
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City of Hope hematologist/oncologist Joseph Alvarnas shares his perspectives on how CAR-T therapies are requiring new models of health care delivery and engagement with more kinds of stakeholders, during an interview at the recent ASH annual meeting.
Having scored a commercial hit with Darzalex in myeloma, Janssen is looking to speed label expansions to the drug to enable it to intercept earlier in the disease. Janssen R&D executive Craig Tendler explained the importance of addressing smoldering myeloma and of recognizing minimal residual disease as a valid surrogate marker in trials.
Amgen sees the approval as a platform to expand blinatumomab into other hematologic malignancies using similar approaches.