[exclusive] list of cancer immunotherapy approved by FDA, CTLA-4, PD-1, PD-L1, car-t

In recent years, cancer immunotherapy has been widely concerned in the medical field Immunotherapy is a kind of treatment method which can control and clear the tumor by restarting and maintaining the tumor immune cycle and restoring the normal anti-tumor immune response of the body It includes monoclonal antibody, therapeutic antibody, cancer vaccine, cell therapy, small molecule inhibitor, etc At present, FDA has approved 11 cancer immunotherapies, the most of which are monoclonal antibody immunocheckpoint inhibitors such as CTLA-4 monoclonal antibody, PD-1 / PD-L1 monoclonal antibody, and the more hot is cell therapy car-t In addition, according to the data of drug intelligence, only one of these approved therapies is listed in China; six import applications have been approved for clinical use, and are in phase 3 clinical use; four applications have not been recorded, as shown in the figure below Provenge (sipuleucel-t) Provenge was developed by dendreon, a Seattle based company On April 29, 2010, it was approved by FDA and became the first vaccine used to treat tumors Provenge is not a preventive vaccine, it is different from measles and hepatitis vaccine Provenge is a therapeutic vaccine for prostate cancer that has been diagnosed It increases the average survival time of patients with advanced prostate cancer by more than four months Yervoy (iilimumab) is developed by Bristol Myers Squibb (BMS), approved by the US Food and Drug Administration (FDA) on March 25, 2011, approved by the European Drug Administration (EMA) on July 13, 2011, and sold in the US and European markets by Bristol Myers Squibb The product name is yervoy Apilimumab is a human cytotoxic T lymphocyte associated antigen 4 (CTLA-4) blocker, which can bind to CTLA-4 to prevent the binding of CTLA-4 to its ligands (CD80 and CD86) Blocking CTLA-4 can increase the activity and proliferation of T cells At present, apilimumab has been approved for 7 indications, three of which are used alone and four are combined therapies, as shown in the following figure: keytruda (pembrolizumab) Pembrolizumab, developed by Merck, was approved by the US Food and Drug Administration (FDA) on September 4, 2014, and approved by the European Drug Administration (EMA) on July 17, 2015, and sold by MSD in the US and European markets under the trade name keytruda Pembrolizumab is a programmed death receptor 1 (PD-1) blocker, which can bind to PD-1 and release the inhibition of PD-1 on T cells At present, the drug has 13 approved indications, one of which is combination therapy, as shown in the following figure: blincyto (blinatumomab) Blinatumomab, developed by Amgen, was approved by the US Food and Drug Administration (FDA) on December 3, 2014, and approved by the European Drug Administration (EMA) on November 23, 2015, and sold by Amgen in the US market under the trade name blincyto Blinatumomab is a double specific adaptor targeting at CD19 and T cell CD3 It forms synapses between CD3 + T cells and CD19 + B-line lymphocytes, and induces CD19 + cell directed cleavage At present, the drug has been approved for three indications, as shown in the figure below Opdivo (nivolumab) nivolumab was jointly developed by Ono and Bristol Myers Squibb (BMS) It was approved by PMDA on July 4, 2014, On December 22, 2014, it was approved by the U.S Food and Drug Administration (FDA), and on June 19, 2015, it was approved by the European Drug Administration (EMA), and it was jointly sold by Ono pharmaceutical and Bristol Myers Squibb in the United States, Europe and Japan, under the trade name of opdivo Nivolumab is a programmed death receptor 1 (PD-1) blocker, which can bind to PD-1 and release the inhibition of PD-1 pathway on T cells Currently, 15 indications have been approved for the drug, including 4 combination therapies, as shown in the figure below At present, opdivo has been listed in China on June 15, 2018, becoming the first PD-1 therapy listed in China Imlygic (talimogene laherparevec (t-vec)) of Amgen was approved by the US FDA on October 27, 2015 for the treatment of skin and lymph node melanoma The drug is also the first anti-tumor virus drug approved by the FDA, with the trade name of imlygic Melanoma is a serious disease that can progress and spread to other parts of the body and then become difficult to treat Tecentriq (atezolizumab) atezolizumab was developed by Genentech (a subsidiary of Roche), which was first approved by FDA on May 18, 2016, under the trade name tecentriq Atezolizumab is a programmed cell death ligand (PD-L1) inhibitor and the first FDA approved PD-L1 inhibitor At present, three indications have been approved, as shown in the figure below: bavencio (avelumab) avelumab is a programmed cell death ligand (PD-L1) inhibitor, initially developed by Merck Serono, and authorized by Pfizer in 2014 to jointly develop and commercialize the drug In 2015, avelumab was certified by the US FDA as an orphan drug for the treatment of Merkel cell carcinoma The first indication was approved on March 23, 2017, followed by another in May, under the trade name bavencio As shown in the figure below: the PD-L1 antibody of imfinzi (durvalumab) durvalumab developed by MedImmune, a subsidiary of AstraZeneca, was then authorized to Xinji company for research on blood related cancer On May 1, 2017, the US Food and Drug Administration (FDA) approved the listing of durvalumab under the trade name of imfinzi At present, the drug has been approved for two indications in total, as shown in the following figure: kymriah (tisagenlecleucel) tisagenlecleucel is a car-t therapy developed by Novartis It was approved by the US FDA on August 30, 2017 for the treatment of relapsed or refractory patients with acute lymphoblastic leukemia (all) under the age of 25 This is the first approved car-t therapy in the world, and the first gene therapy product in the U.S market, with milestone significance Life threatening side effects that may occur during car-t treatment include cytokine release syndrome (CRS) and neurotoxicity The cost of a single treatment was $475000 Has the drug been approved for two indications? As shown in the following figure: on December 18, 2017, the FDA announced the approval of car-t therapy of kit Pharma, a subsidiary of Gilead science Inc., for the treatment of adult patients with certain types of large B-cell lymphoma These patients received at least two other treatments, but did not show remission or relapse Axicabtagene ciloleucel (kte-c19) enables patients' own T cells to be designed and express car, targeting CD19 antigen, and reorienting T cells to kill tumor cells It is worth mentioning that this is the first FDA approved car-t therapy for specific non Hodgkin's lymphoma and the second approved car-t therapy Note: part of the information comes from the open information on the Internet, and the relevant declaration information comes from the pharmaceutical intelligence data