The FDA ( Food and Drug Administration ) has granted Breakthrough Therapy designation to Keytruda ( Pembrolizumab ), an anti-PD-1 therapy, for the treatment of patients with relapsed or refractory classical Hodgkin lymphoma ( cHL ).
This is the fourth Breakthrough Therapy Designation granted for Keytruda.
The FDA’s Breakthrough Therapy Designation is intended to expedite the development and review of a candidate that is planned for use, alone or in combination, to treat a serious or life-threatening disease or condition when preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints.
Keytruda was previously granted breakthrough status for specific patients with advanced melanoma, advanced non-small cell lung cancer ( NSCLC ), and advanced colorectal cancer.
The Breakthrough Therapy Designation in classical Hodgkin lymphoma is based on data from the ongoing phase 1b KEYNOTE-013 and phase 2 KEYNOTE-087 studies evaluating single agent Pembrolizumab in patients with classical Hodgkin lymphoma.
Pembrolizumab is a humanized monoclonal antibody that works by increasing the ability of the body’s immune system to help detect and fight tumor cells.
Pembrolizumab blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.
Keytruda is indicated for the treatment of patients with: unresectable or metastatic melanoma, metastatic non-small cell lung cancer ( NSCLC ) whose tumors express PD-L1.
Keytruda is administered at a dose of 2 mg/kg as an intravenous infusion over 30 minutes every three weeks for the approved indications.
Lymphoma is a type of blood cancer that affects the lymphatic system, which removes excess fluids from the body and produces immune cells. Lymphoma cells are abnormal lymphocytes which multiply and collect in the lymph nodes and other tissues. Hodgkin lymphoma ( also called Hodgkin disease ) is a specific type of lymphoma and includes two subtypes: classical Hodgkin lymphoma ( cHL ) and nodular lymphocyte predominant Hodgkin lymphoma.
In 2016, it is estimated that more than 8,500 people will be diagnosed with Hodgkin lymphoma in the U.S. alone and cHL accounts for 95% of all Hodgkin lymphoma cases. ( Xagena )
Source: Merck, 2016