Dostarlimab
Highest phase reached
Approved
Drug type
Antibody
First approval year
2021
- First approval year
- 2021
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Antibody
- Drug name
- Dostarlimab
- jemperli
- Jemperli
- dostarlimab
- Dostarlimab
- Dostarlimab (TSR-042)
- Dostarlimab (TSR-042) (singly)
- dostarlimab [INN]
- Dostarlimab [MI]
- DOSTARLIMAB [USAN]
- Dostarlimab [WHO-DD]
- dostarlimab gxly
- Dostarlimab gxly
- Dostarlimab gxly [WHO-DD]
- dostarlimab gxly who dd
- dostarlimab inn
- dostarlimab mi
- dostarlimab usan
- dostarlimab who dd
- Dostarlimab-gxly
- gsk 4057190
- GSK-4057190
- gsk4057190
- GSK4057190
- tsr 042
- Tsr 042
- Tsr-042
- TSR-042
And 8 more, listed on the interactive page.
- ATC classification codes
- L01FF07
Sources for recorded values
- CAS registry numbers
- 2022215-59-2
- ChEMBL ID
- CHEMBL4298124
- FDA ingredient codes (UNII)
- P0GVQ9A4S5
- 2539967
- 2539968
- Applicant
- GLAXOSMITHKLINE
- Approval date
- 22 Apr 2021
- Application number
- BLA761174
- Status
- Authorised
- Status date
- 21 Apr 2021
- Authorisation date
- 21 Apr 2021
- Approved indications
- Jemperli is indicated in combination with carboplatin and paclitaxel for the first-line treatment of adult patients with primary advanced or recurrent endometrial cancer (EC) and who are candidates for systemic therapy. Jemperli is indicated as monotherapy for the treatment of adult patients with mismatch repair deficient (dMMR)/ microsatellite instability‑high (MSI‑H) recurrent or advanced EC that has progressed on or following prior treatment with a platinum‑containing regimen.
- Product number
- EMEA/H/C/005204
- Authorisation holder
- GlaxoSmithKline Trading Services Limited
- Priority medicines scheme
- No
- Generic
- No
- Biosimilar
- No
- Generic medicines
- 0
- Biosimilar medicines
- 0
- Advanced therapy
- No
- Conditional approval
- No
- Additional monitoring
- Yes
- Accelerated assessment
- No
- Exceptional circumstances
- No
Therapeutic areas
- Endometrial Neoplasms
European medicines record
- Patents
- 0
- Designations
- 4
- First in class
- No
- Fast track
- No
- Breakthrough designation
- Yes
- Orphan designation
- No
- Priority review
- Yes
- Orphan exclusivity
- No
- Accelerated approval
- Yes
- Availability
- Prescription only
- Pharmacology name
- dostarlimab
- Type
- Antibody
- Drug name stem
- -mab
- Approval recorded by Guide to Pharmacology
- Yes
Administration routes
- Parenteral
- Mechanism
- Programmed cell death protein 1 antagonist
- Action type
- Antagonist
- Target
- Programmed cell death protein 1
- Protein identifier
- Q15116
- Action
- Binding
- Action type
- Binding
- Target
- programmed cell death 1 (CD279)
- Gene symbol
- PDCD1
- Protein identifier
- Q15116
- Primary target
- Yes
Open Targets mechanisms
- Mechanism
- Programmed cell death protein 1 antagonist
- Action type
- Antagonist
- Target
- Programmed cell death protein 1
- Condition
- Carcinoma, Squamous Cell
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000181
- Subject identifier
- D002294
- Condition
- Carcinoma
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000313
- Subject identifier
- D002277
- Condition
- Adenocarcinoma, Clear Cell
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000348
- Subject identifier
- D018262
- Condition
- Mesothelioma
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000588
- Subject identifier
- D008654
- Condition
- Neoplasms
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000616
- Subject identifier
- D009369
- Condition
- Sarcoma
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000691
- Subject identifier
- D012509
- Condition
- Small Cell Lung Carcinoma
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000702
- Subject identifier
- D055752
- Condition
- Melanoma
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000756
- Subject identifier
- D008545
- Condition
- Uterine Cervical Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- EFO:0001061
- Subject identifier
- D002583
- Condition
- Multiple Myeloma
- Highest recorded phase
- 1
- Condition identifier
- EFO:0001378
- Subject identifier
- D009101
- Condition
- Pancreatic Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- EFO:0002618
- Subject identifier
- D010190
- Condition
- Carcinoma, Non-Small-Cell Lung
- Highest recorded phase
- 3
- Condition identifier
- EFO:0003060
- Subject identifier
- D002289
- Condition
- Breast Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- EFO:0003869
- Subject identifier
- D001943
- Condition
- Ovarian Neoplasms
- Highest recorded phase
- 3
- Condition identifier
- EFO:0003893
- Subject identifier
- D010051
- Condition
- Hemangiosarcoma
- Highest recorded phase
- 2
- Condition identifier
- EFO:0003968
- Subject identifier
- D006394
- Condition
- Colonic Neoplasms
- Highest recorded phase
- 3
- Condition identifier
- EFO:0004288
- Subject identifier
- D003110
- Condition
- Head and Neck Neoplasms
- Highest recorded phase
- 3
- Condition identifier
- EFO:0005950
- Subject identifier
- D006258
- Condition
- Head and Neck Neoplasms
- Highest recorded phase
- 3
- Condition identifier
- EFO:0006859
- Subject identifier
- D006258
- Condition
- Penile Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- EFO:1000465
- Subject identifier
- D010412
- Condition
- Rectal Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- EFO:1000657
- Subject identifier
- D012004
- Condition
- Colorectal Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- EFO:1001951
- Subject identifier
- D015179
- Condition
- Rectal Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- MONDO:0002165
- Subject identifier
- D012004
- Condition
- Liver Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- MONDO:0002691
- Subject identifier
- D008113
- Condition
- Uterine Cervical Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- MONDO:0002974
- Subject identifier
- D002583
- Condition
- Neoplasms
- Highest recorded phase
- 4
- Condition identifier
- MONDO:0004992
- Subject identifier
- D009369
And 8 more, listed on the interactive page.
- Condition identifier
- EFO_0000348
- Condition identifier
- EFO_0000616
- Condition identifier
- EFO_0000691
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000756
- Highest recorded phase
- 2
- Condition identifier
- EFO_0001378
- Highest recorded phase
- 2
- Condition identifier
- EFO_0003060
- Highest recorded phase
- 2
- Condition identifier
- EFO_0003893
- Highest recorded phase
- 3
- Condition identifier
- EFO_0004230
- Highest recorded phase
- 4
- Condition identifier
- EFO_0005950
- Highest recorded phase
- 3
- Condition identifier
- EFO_1000465
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0000548
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0001056
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0002087
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0002120
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0002158
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0002165
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0002169
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0002670
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0002691
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0002926
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0002928
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0002974
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0003059
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0004986
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0004992
- Highest recorded phase
- 2
And 33 more, listed on the interactive page.
- Event
- autoimmune haemolytic anaemia
- Reports
- 2
- Reporting signal score
- 5.86747
- Event
- disorientation
- Reports
- 4
- Reporting signal score
- 5.89757
- Event
- embolism
- Reports
- 3
- Reporting signal score
- 7.75348
- Event
- immunotoxicity
- Reports
- 1
- Reporting signal score
- 7.84945
- Event
- myocarditis
- Reports
- 3
- Reporting signal score
- 7.08625
- Event
- platelet count decreased
- Reports
- 7
- Reporting signal score
- 7.1774
- Event
- pneumonitis
- Reports
- 8
- Reporting signal score
- 19.3809
- Event
- stress cardiomyopathy
- Reports
- 5
- Reporting signal score
- 16.2678
- Event
- subacute cutaneous lupus erythematosus
- Reports
- 2
- Reporting signal score
- 6.52949
- Event
- thrombocytopenia
- Reports
- 7
- Reporting signal score
- 5.70463
- NCT01042379
- NCT04837209
- NCT02715284
- NCT02723955
- NCT02817633
- NCT03250832
- NCT03308942
- NCT03739710
- NCT03843359
- NCT03981796
- NCT04446351
- NCT04544995
- NCT05277051
- NCT06322693
- NCT03016338
- NCT04774419
- NCT05201547
- NCT05819892
- NCT06385548
- NCT03574779
- NCT03602859
- NCT03955471
- NCT05751629
- NCT03654833
- NCT03680508
And 30 more, listed on the interactive page.
- Dose
- 500mg, 1,000mg
- Route
- Intravenous
- How often
- Every 3 weeks for 4 or 6 cycles, then every 6 weeks
Conditions of use
- Administer as an intravenous infusion over 30 minutes
- Prodrug
- No
- Chirality
- Single enantiomer
- Inorganic
- No
- Natural product
- No
- Component
- Glycosylation sites (N)
- Sequence
- Asn-293$Asn-293''''
- Component
- Light chain
- Type
- Protein
- Sequence
- DIQLTQSPSFLSAYVGDRVTITCKASQDVGTAVAWYQQKPGKAPKLLIYWASTLHTGVPSRFSGSGSGTEFTLTISSLQPEDFATYYCQHYSSYPWTFGQGTKLEIKRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC
- Component
- Heavy chain
- Type
- Protein
- Sequence
- EVQLLESGGGLVQPGGSLRLSCAASGFTFSSYDMSWVRQAPGKGLEWVSTISGGGSYTYYQDSVKGRFTISRDNSKNTLYLQMNSLRAEDTAVYYCASPYYAMDYWGQGTTVTVSSASTKGPSVFPLAPCSRSTSESTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTKTYTCNVDHKPSNTKVDKRVESKYGPPCPPCPAPEFLGGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSQEDPEVQFNWYVDGVEVHNAKTKPREEQFNSTYRVVSVLTVLHQDWLNGKEYKCKVSNKGLPSSIEKTISKAKGQPREPQVYTLPPSQEEMTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSRLTVDKSRWQEGNVFSCSVMHEALHNHYTQKSLSLSLGK
- Component
- Glycosylation sites (N)
- Sequence
- Asn-293$Asn-293''
- Component
- Disulfide bridges location
- Sequence
- 22-96$22''-96''$23'-88'$23'''-88'''$130-214'$130''-214'''$134'-194'$134'''-194'''$143-199$143''-199''$222-222''$225-225''$257-317$257''-317''$363-421$363''-421''
- 0173-0898
Related records
Trials (99)
- A Comparison of Platinum-based Therapy With TSR-042 and Niraparib Versus Standard of Care (SOC) Platinum-based Therapy as First-line Treatment of Stage III or IV Nonmucinous Epithelial Ovarian Cancer
- A Comprehensive Multiomic Biomarker Evaluation Across Two Single-arm Cohorts to Elucidate Mechanisms of Response and Resistance in Recurrent/Metastatic (R/M) Head and Neck Squamous Cell Carcinoma (HNSCC)
- A First Time in Human (FTIH) Study of GSK3745417 Administered to Participants With Advanced Solid Tumors
- A Platform Study of Novel Immunotherapy Combinations as First-Line Treatment in Participants With PD-L1 Positive Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck- GALAXIES H&N-202
- A Platform Study of Novel Immunotherapy Combinations in Participants With Previously Untreated, Advanced/Metastatic Non-Small-Cell Lung Cancer
- A Safety Study Adding Niraparib and Dostarlimab to Radiation Therapy for Rectal Cancers
- A Study of Belrestotug Plus Dostarlimab Compared With Placebo Plus Pembrolizumab in Previously Untreated Participants With Programmed Death Ligand 1 (PD-L1) High Non-small-cell Lung Cancer (NSCLC)
- A Study of Cobolimab Plus Dostarlimab in Pediatric and Young Adult Participants With Cancer
- A Study of Dostarlimab in Combination With Carboplatin-paclitaxel in Chinese Participants With Primary Advanced or Recurrent Endometrial Cancer (EC)
- A Study of Dostarlimab in Combination With Carboplatin-paclitaxel in Japanese Participants With Primary Advanced or Recurrent Endometrial Cancer
- A Study of Dostarlimab in Participants With Untreated Locally Advanced Rectal Cancer in China
- A Study of Dostarlimab in Untreated dMMR/MSI-H Locally Advanced Rectal Cancer
- A Study of Dostarlimab vs Placebo After Chemoradiation in Adult Participants With Locally Advanced Unresected Head and Neck Squamous Cell Carcinoma
- A Study of GSK5764227 in Participants With Advanced Solid Tumors (EMBOLD)
- A Study of Mocertatug Rezetecan in Combination With Anti-cancer Therapies for Advanced Solid Tumors (BEHOLD-2)
- A Study of Neoadjuvant Dostarlimab Plus Capecitabine Plus Oxaliplatin (CAPEOX) Vs CAPEOX With Previously Untreated T4N0 or Stage III Mismatch Repair Proficient (MMRp)/Microsatellite Stable (MSS) Colon Cancer
- A Study of Roginolisib (IOA-244) in Combination With Dostarlimab With or Without Docetaxel in Metastatic Non Small-cell Lung Cancer (NSCLC) Patients
- A Study of the Duration of Dostarlimab in Untreated Mismatch Repair Deficient (dMMR)/ Microsatellite Instability-high (MSI-H) Locally Advanced Rectal Cancer
- A Study of TSR-022 in Participants With Advanced Solid Tumors (AMBER)
- A Study to Evaluate Dostarlimab Plus Carboplatin-paclitaxel Versus Placebo Plus Carboplatin-paclitaxel in Participants With Recurrent or Primary Advanced Endometrial Cancer
Approved for (4)
- Cancer
- Endometrial cancer
- Endometrium neoplasm
- Neoplasm
In development for (30)
- Angiosarcoma Phase 2
- Breast cancer Phase 2
- Breast neoplasm Phase 2
- Carcinoma Phase 2
- Cervical cancer Phase 2
- Cervical carcinoma Phase 2
- Clear cell adenocarcinoma Phase 1
- Colonic neoplasm Phase 3
- Colorectal carcinoma Phase 2
- Exocrine pancreatic carcinoma Phase 2
- Gestational trophoblastic neoplasm Phase 2
- Head and neck cancer Phase 3
- Head and neck neoplasm Phase 3
- Head and neck squamous cell carcinoma Phase 1
- Hereditary breast ovarian cancer syndrome Phase 2
- Liver cancer Phase 2
- Malignant colon neoplasm Phase 3
- Melanoma Phase 2
- Mesothelioma Phase 2
- Metastatic malignant neoplasm Phase 1
Targets (1)
- PDCD1 Programmed cell death protein 1 antagonist