The FDA has granted Priority Review to the Biologics License Application (BLA) of belantamab mafodotin (GSK2857916; GlaxoSmithKline) for the treatment of patients with relapsed or refractory multiple myeloma whose prior therapy included an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody.
Currently, splenomegaly is not included as a prognostic factor in major prognostic models of Philadelphia-negative myeloproliferative neoplasms.
Progression-free survival, overall survival, and percentage of patients who achieved very good partial response or better were similar between both treatment groups.
For the entire cohort of pediatric patients with standard-risk acute lymphoblastic leukemia, overall survival at 6 years was greater than 95%.
The study’s primary endpoint was efficacy, determined by complete remission, peripheral blood cell count remission, quality of life, and JAK2 V617F allele burden.
Median progression-free survival was 34.2 months in patients who received ofatumumab and 16.9 months in patients who received no additional treatment.
Although CAR-T therapies have shown favorable response rates, they can be incredibly costly and may not be priced in alignment with their benefits.
Despite an overall response rate of 57%, this clinical trial was suspended due to safety concerns then closed early due to insufficient activity of the study drug combination.
Even though overall drug development times have not changed, questions about the clinical benefit of the drugs that have been approved through expedited pathways are being raised.
A study of an Asian population failed to find a link between the virus and malignancies outside of the liver.
