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The research may inform the use of a liquid biopsy assay for tracking SMM progression that improves on bone marrow aspirate analysis and is easier for patients to access.
The agency approved the drug based on a study that showed an 88 percent response rate in young patients with ALK-positive anaplastic large cell lymphoma.
A data safety monitoring committee said the trial, exploring the first-line activity of bintrafusp against Keytruda in PD-L1-high, advanced NSCLC, wouldn't meet its primary endpoint.
The final decision includes some changes, most notably removing requirements for guideline inclusion, but retains its technical performance benchmarks.
The recommendation would make the cell therapy available to patients in the National Health Service, while NICE continues collecting long-term survival data.
News items for the week of Jan. 18, 2021.
The firm will consolidate its businesses in newly-built headquarters in Fort Myers, Florida, which it plans to occupy around September.