What is an SPA or Special Protocol Assessment?

What is an SPA or Special Protocol Assessment?

SPA or Special Protocol Assessment is an agreement arrived at between the FDA and a drug sponsor planning a pivotal trial. If certain trial design, endpoints and outcomes are met, the FDA basically agrees to approve the drug without requiring any additional trials. Without an SPA, the sponsor may submit an NDA with a certain endpoint - say, CR/PR - when the FDA can say that they will accept nothing less than OS as an endpoint. So, the drug gets rejected. However, if the sponsor had an SPA where the FDA agreed to CR/PR as adequate endpoints, then, assuming the trial met the required CR/PR threshold, the FDA must necessarily approve the drug. In some cases, the FDA may issue a CRL despite an SPA. But overall, a company with an SPA has a valuable asset.

What is a monoclonal antibody?

A monoclonal antibody or mAb is an antibody produced in the laboratory from a single ancestral plasma cell

What Is Non-Hodgkin Lymphoma?

Non-Hodgkin lymphoma (also known as non-Hodgkin’s lymphoma or NHL) is a cancer of the lymphocytes, a type of white blood cells and an important part of the immune system.

What is INI1 and SMARCA4?

INI1 and SMARCA4 are subunits of SWI/SNF, a chromatin modifying protein complex, which opposes the activity of PRC2, the complex within which EZH2 resides.