Skip to main content
main-content

16-03-2017 | Lenalidomide | Drug approval | News

approvalsWatch

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.

By Lynda Williams

medwireNews is an independent medical news service provided by Springer Healthcare. © 2017 Springer Healthcare part of the Springer Nature group

Related topics