FDA approvals granted for lenalidomide, pembrolizumab and ribociclib
The US FDA has approved lenalidomide 10 mg/day as a maintenance therapy for patients who have undergone autologous stem cell transplantation for multiple myeloma. The recommendation is based on results from two randomized clinical trials showing progression-free survival benefit with the thalidomide analog compared with placebo.
Pembrolizumab has been given accelerated approval for the treatment of adult and pediatric classical Hodgkin lymphoma that is refractory to or has relapsed after autologous stem cell transplantation and/or treatment with brentuximab vedotin. The approval, granted alongside Orphan Drug Designation and Breakthrough Therapy Designation, was based on response findings from a clinical trial of adult patients, with efficacy extrapolated to occur in children.
However, safety analyses from the classical Hodgkin lymphoma trial and a second study of children with advanced melanoma, PD-L1-positive tumours, or lymphoma showed similar profiles of adverse events, leading to the requirement for long-term safety evaluation in prepubertal children and those going through puberty.
In addition a Warning and Precaution was added requiring further follow-up on the safety of pembrolizumab in patients who have previously undergone allogeneic hematopoietic stem cell transplantation.
The CDK 4/6 inhibitor ribociclib has been granted approval for use alongside an aromatase inhibitor for the first-line treatment of postmenopausal women with hormone receptor-positive, HER2-negative advanced or metastatic breast cancer.
The approval follows preplanned interim results from the MONALEESA-2 trial demonstrating significant improvements in progression-free survival and objective response rate with ribociclib plus letrozole versus placebo with letrozole.
The recommended ribociclib dose is 600 mg/day for 21 days of a 28-day cycle.
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