Merck, commonly known as MSD, has obtained breakthrough therapy designation from the US Food and Drug Administration (FDA) for its Keytruda (pembrolizumab) to treat patients with relapsed or refractory classical Hodgkin lymphoma (cHL).

Hodgkin lymphoma is a specific type of lymphoma and includes two subtypes: cHL and nodular lymphocyte predominant Hodgkin lymphoma.

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 that multiply and collect in the lymph nodes and other tissues.

"The FDA’s breakthrough designation for this blood cancer provides an important mechanism to assist us in bringing this immunotherapy to patients who could benefit from its use."

Keytruda is a humanised monoclonal antibody that increases the ability of the body’s immune system to help detect and fight tumour cells.

It activates T lymphocytes that may affect both tumour cells and healthy cells, by blocking the interaction between PD-1 and its ligands, PD-L1 and PD-L2.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

Merck Research Laboratories president Dr. Roger M. Perlmutter said: "Merck has launched an ambitious clinical development programme examining the efficacy of Keytruda in a broad range of solid and blood cancers, and our studies of relapsed or refractory classical Hodgkin lymphoma are quite promising.

"The FDA’s breakthrough designation for this blood cancer provides an important mechanism to assist us in bringing this immunotherapy to patients who could benefit from its use."

The designation has been provided based on a data from ongoing Phase Ib KEYNOTE-013 and Phase II KEYNOTE-087 studies, which assessed efficacy of Keytruda.

Keytruda also obtained breakthrough status to treat specific patients with advanced melanoma, advanced non-small cell lung cancer (NSCLC), and advanced colorectal cancer.