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BMS submitted LAG-3+PD-1 fixed-dose compound market application and received FDA priority review

 Last Update: 2021-09-30
 Source: Internet
 Author: User

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Article source: Medical Rubik's Cube Info

On September 20, BMS announced that the FDA has accepted the marketing application of relatlimab (LAG-3) + nivolumab (PD-1) fixed-dose combination combination for the treatment of unresectable or unresectable or non-resectable or For metastatic melanoma, PDUFA's scheduled approval period is March 19, 2022
.

Lymphocyte activation gene-3 (LAG-3) and programmed death receptor-1 (PD-1) are two different inhibitory immune checkpoints, usually co-expressed in tumor-infiltrating lymphocytes (TILs) and cause tumors Mediated T cell failure
.

The combination therapy of the new LAG-3 blocking antibody relatlimab and PD-1 inhibitor nivolumab can activate T cells, thereby triggering an improved immune response and promoting tumor cell death

On May 19 this year, BMS published the clinical trial data of Phase II/III RELATIVITY-047 study
.

The results showed that the fixed-dose combination of relatlimab and nivolumab as a first-line therapy for previously untreated patients with metastatic or unresectable melanoma achieved statistically and clinically significant progression-free survival (PFS) benefits compared to Opdivo monotherapy (10.

The safety of the fixed-dose combination therapy of Relatlimab and Opdivo is controllable, consistent with the previously reported situation
.

Compared with Opdivo monotherapy, the combination therapy found no new safety signals or new clinically important events

If the combination therapy is approved, relatlimab will be the third type of immune checkpoint inhibitor listed after CTLA4 and PD1-1/PD-L1

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