FDA clears new drug application for CAR-T cell therapy for the treatment of solid tumours
This month, the Food and Drug Administration (FDA) cleared an investigational new drug application for a chimeric antigen receptor (CAR) T-cell therapy called P-MUC1C-ALL01, designed to treat adults with locally advanced or metastatic solid tumours. The investigational new drug application is specific to patients who are resistant to standard of care therapies or are ineligible to other existing treatment options.
CAR T-cell therapy is a type of immunotherapy approach that genetically engineers T cells, the “workhorses” of the body’s immune system, to produce receptors on their surface that allow them to recognize a specific protein, or antigen, on the surface of tumour cells. After the new T cells are made and their numbers expanded in the laboratory, they are infused into the patient. With guidance from the engineered receptor, the novel T-cells recognize and kill cancer cells that express the targeted antigen.
In 2017, two CAR T-cell therapies were approved by the FDA – one for a type of childhood leukemia and the other for adults with advanced lymphoma. Thus far, the efficacy of CAR T-cell therapy in solid tumours has not been supported, and this therapy remains accessible through clinical trials only. The recent FDA clearance will allow Poseida, the manufacturer of the P-MUC1C-ALL01 CAR T-cell therapy, to begin enrolling patients in the clinical trial which will evaluate the therapy’s safety, tolerability and efficacy among patients with advanced or metastatic solid tumours including breast, colorectal, lung, ovarian, pancreatic and renal cancers.
Take away message:
While CAR T-cell therapies have been approved in certain types of leukemia and lymphoma, their efficacy has not been supported among solid tumours. A CAR T-cell therapy manufacturer recently received approval from the FDA to begin enrollment for a clinical trial to evaluate the safety, tolerability and efficacy of a novel CAR T-cell therapy for the treatment of advanced solid tumours including colorectal.