The FDA grants KEYTRUDA® (pembrolizumab) Priority Review for the possible treatment of cHL
Keytruda®, or pembrolizumab, is a PD-1 inhibitor which has recently been accepted for Priority Review by the U.S. Food and Drug Administration (FDA) for the treatment of classical Hodgkin Lymphoma (cHL) in refractory patients or those who have relapsed after three lines of therapy.
The review is based on the KEYNOTE-013 phase I trial (NCT01953692) and KEYNOTE-087 phase II trial (NCT02453594) which showed positive data at a 200mg dose every three weeks. Updated long-term data on KEYNOTE-013 was presented this December at ASH 2016 and showed a durable response with an ORR of 58% and CRR of 19%.
Pembrolizumab was also a topic of discussion during an educational session at ASH 2016, titled “Novel agents and strategies in transplant-eligible patients with relapsed and refractory Hodgkin Lymphoma” presented by Craig Moskowitz, one of the principal investigators on the KEYNOTE-087 trial.
The expected target action date is currently set to be March 15th 2017.
- Zinzani, P.L. et al. Phase 1b Study of PD-1 Blockade with Pembrolizumab in Patients with Relapsed/Refractory Primary Mediastinal Large B-Cell Lymphoma (PMBCL). Blood. 3 Dec. 2015. DOI: 126.23 (2015): 3986.
- Chen, R. et al. Phase II study of pembrolizumab (MK-3475) for relapsed/refractory classical Hodgkin Lymphoma (r/r cHL): keynote-087. J Immunother Cancer. 4 Nov. 2015 DOI: 10.1186/2051-1426-3-S2-P146.
- CureToday online. December 1st http://www.curetoday.com/articles/keytruda-granted-priority-review-for-hodgkin-lymphoma. [Accessed December 2016].