Bristol Myers Squibb car-t therapy qualified for priority review

Today, Bristol Myers Squibb (BMS) announced that the U.S FDA has accepted its car-t therapy lisocabatagene targeting CD19 antigen Maraleucel (LISO CEL) is a biologicals licensing application (BLA) for the treatment of relapsed / refractory (R / R) large B-cell lymphoma (lbcl) in adult patients, including diffuse large B-cell lymphoma (DLBCL), who have received at least two types of pre-treatment At the same time, FDA has granted it priority review qualification, and it is expected to reply before August 17 this year Diffuse large B-cell lymphoma (DLBCL) is the most common malignant lymphoma in the world, and it is also the invasive form of non-Hodgkin's lymphoma (NHL) Between 30% and 40% of patients with DLBCL have no remission or relapse after first-line treatment Patients who cannot receive first-line treatment and are not suitable for high-dose chemotherapy (HDC) and autologous stem cell transplantation (ASCT) have poor prognosis, and they urgently need more treatment options LISO cel is an auto car-t therapy targeting CD19 antigen It has been awarded the breakthrough therapy certification and advanced regenerative medicine therapy certification (rmat) by FDA The unique feature of this therapy is that the proportion of CD8 positive and CD4 positive T cells in car-t therapy is controlled, which can better control the side effects of cell therapy This application is based on the efficacy and safety data of LISO cel in the clinical trial named transcend NHL 001 According to the press release, the trial is the largest study currently supporting car-t therapy targeted at CD19 antigen submitted by bla The results of this trial showed that the overall response rate (ORR) was 73% in 256 evaluable patients, of which 53% achieved complete response (CR) ▲ efficacy data of LISO cel (picture source: BMS official website) In terms of safety, the severe (grade 3 or above) cytokine release syndrome (CRS) produced by this car-t therapy only occurs in 2% of patients, and only 10% of patients have severe neurotoxicity of grade 3 or above ▲ security data of LISO cel (picture source: BMS official website) "For patients with large B-cell lymphoma, especially those with relapse or refractory disease, they urgently need other therapies," said Stanley Frankel, MD, senior vice president of Bristol Myers Squibb cell therapy According to the data of the 001 trial, LISO cel has the potential to expand the treatment options for those patients who have no remission after receiving the initial treatment or whose disease has recurred The FDA's acceptance of this application and the granting of its priority review status is an important step in improving the treatment process for these patients " reference material: [1] U.S Food and Drug Administration (FDA) Accepts for Priority Review Bristol-Myers Squibb’s Biologics License Application (BLA) for Lisocabtagene Maraleucel (liso-cel) for Adult Patients with Relapsed or Refractory Large B-Cell Lymphoma, Retrieved February 13, 2020, from https://news.bms.com/press-release/us-food-and-drug-administration-fda-accepts-priority-review-bristol-myers-squibbs-biol A kind of