Posted by Michael Wonder on 29 Jul 2018
PTAC defers submission for new indication for PD-L1 antagonist
27 July 2018 - This time its for patients with Hodgkin's disease. The reason; PTAC wants to see updated data for another medicine.
The PTAC considered a submission from MSD in May for pembrolizumab for the treatment of patients with classical Hodgkin's disease which has relapsed after two lines of chemotherapy and is either ineligible for or relapsed following an autologous stem cell transplant.
The Committee recommended that the application for pembrolizumab for the treatment of classical Hodgkin's disease which has relapsed after two lines of chemotherapy and is either ineligible for or relapsed following an autologous stem cell transplant be deferred until the updated evidence for brentuximab vedotin published since the last PTAC consideration is reviewed by Cancer Treatment Subcommittee of PTAC.
The Committee recommended that the application for pembrolizumab for the treatment of classical Hodgkin's disease which has relapsed after two lines of chemotherapy and is either ineligible for or relapsed following an autologous stem cell transplant be referred to the Cancer Treatment Subcommittee of PTAC, with their view sought on the health benefits of pembrolizumab and brentuximab vedotin in this setting, clarity in the treatment sequencing and the role of alloSCT if pembrolizumab were funded and provide advice on special authority criteria.
