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The Clinical Landscape Of ADC

Updated Research & Clinical trial information on antibody-drug conjugates (ADCs) for multiple indications in oncology and hematology

Antibody-drug Conjugates

The information on this page is limited to commercially available antibody-drug conjugates approved by the U.S. Food and Drug Administration (FDA) and intended for U.S. healthcare professionals (HCP) only. If you are not a U.S. healthcare professional, do not continue on this page.


Ado-trastuzumab emtansine (Kadcyla®)

International Nonproprietary Name (INN)HCP WebsitePrescribing InformationNDC
Ado-trastuzumab emtansineHCP WebsitePrescribing InformationNDC 50242-088-01 NDC 50242-087-01
Brand NameEHR ResourcesDrug DescriptionFDA
Kadcyla® Drug description2013
Marketing LicensePatient InformationDrug MapEMA
Genentech/Roche Link 
Access DataPatient AssistantCondition 
  HER2+ breast cancer 
Additional info   
Ado-trastuzumab emtansine (Kadcyla®; Genentech/Roche), as a single agent, is indicated for the treatment of patients with HER2-positive (HER2+), metastatic breast cancer (MBC) who previously received trastuzumab and a taxane, separately or in combination. Patients should have either:

  • Received prior therapy for metastatic disease, or
  • Developed disease recurrence during or within six months of completing adjuvant therapy

Belantamab mafodotin (Blenrep™)

International Nonproprietary Name (INN)HCP WebsitePrescribing InformationNDC
Belantamab mafodotin-blmf** Prescribing InformationNDC 0173­ 0896-01
Brand NameEHR ResourcesDrug DescriptionFDA
 EHR Resources Conditional 2020*
Marketing LicensePatient InformationDrug MapEMA
GSK   
Access DataPatient AssistantCondition 
  refractory Multiple Myeloma 
Additional info   
Belantamab mafodotin-blmf (Blenrep™; GSK) is a B-cell maturation antigen (BCMA)-directed antibody and microtubule inhibitor conjugate indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least 4 prior therapies including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent. This indication is approved under accelerated approval based on the response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). The recommended dosage is 2.5 mg/kg as an intravenous infusion over approximately 30 minutes once every 3 weeks (Q3W).



* In November 2022, after an update from the phase 3 DREAMM-3 study the use of belantamab monotherapy for previously treated patients with relapsed or refractory multiple myeloma was pulled from US market authorization by request of the US Food and Drug Administration (FDA).


Brentuximab Vedotin (Adcetris®)

International Nonproprietary Name (INN)HCP WebsitePrescribing InformationNDC
Brentuximab vedotinHCP WebsitePrescribing InformationNDC 51144-050-01
Brand NameEHR ResourcesDrug DescriptionFDA
Adcetris®  2011
Marketing LicensePatient InformationDrug MapEMA
Seagen   
Access DataPatient AssistantDrug UpdatesCondition
  Updates DrugHodgkin lymphoma, systemic anaplastic large cell lymphoma
Additional info   
Brentuximab vedotin (Adcetris®; Seattle Genetics)  is approved by the U.S. Food and Drug Administration for the treatment of adult patients with primary cutaneous anaplastic large cell lymphoma (pcALCL) or CD30-expressing mycosis fungoides (MF) who have received prior systemic therapy (treatment that reaches and affects the entire body). The drug is also approved for the treatment of patients with:

  • Classical Hodgkin lymphoma (HL) after failure of autologous hematopoietic stem cell transplantation (auto-HSCT) or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not auto-HSCT candidates.
  • Classical HL at high risk of relapse or progression as post auto-HSCT consolidation treatment.
  • Systemic anaplastic large cell lymphoma (sALCL) after failure of at least one prior multi-agent chemotherapy regimen.
  • The sALCL indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Additional information:


Enfortumab Vedotin-ejfv (Padcev™)

International Nonproprietary Name (INN)HCP WebsitePrescribing InformationNDC
Enfortumab vedotinHCP WebsitePrescribing InformationNDC 51144-020-01 NDC 51144-030-01
Brand NameEHR ResourcesDrug DescriptionFDA
Padcev™ Drug Description2019
Marketing LicensePatient InformationDrug MapEMA
Astellas Pharma / Seagen   
 Access Data/Patient AssistantCondition 
 Access Data/Patient AssistanceUrothelial cancer 
Additional info   
Enfortumab vedotin (Padcev™; Astellas Pharma / Seattle Genetics) is a Nectin-4-directed antibody and microtubule inhibitor conjugate indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor, and platinum-containing chemotherapy in the neoadjuvant/adjuvant, locally advanced or metastatic setting. This indication is approved under accelerated approval based on the tumor response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.


Additional Information


Fam-trastuzumab deruxtecan-nxki (Enhertu®)

International Nonproprietary Name (INN)HCP WebsitePrescribing InformationNDC
Fam-trastuzumab deruxtecan-nxkiHCP WebsitePrescribing InformationNDC 65597-406-01
Brand NameEHR ResourcesDrug DescriptionFDA
Enhertu®  2019
Marketing LicensePatient InformationDrug MapEMA
Daiichi Sankyo / AstraZenecaPatient Information  
 Access Data/Patient AssistantCondition 
  HER2+ breast cancer 
Additional info   
Fam-trastuzumab deruxtecan-nxki (Enhertu®; Daiichi Sankyo and AstraZeneca),* formerly known as DS-8201, is a targeted anti-cancer drug that delivers a novel topoisomerase I inhibitor payload to cancer cells via a cleavable tetrapeptide-based linker attached to a  monoclonal antibody. The antibody binds to specific HER2 targets expressed on cancer cells. The newly approved antibody-drug conjugates uses Daiichi Sankyo’s proprietary DXd ADC technology. The HER2 directed antibody-drug conjugate is approved for the treatment of adult patients with advanced, unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based treatments in the metastatic setting. * Fam-trastuzumab deruxtecan-nxki in the US only, trastuzumab deruxtecan outside the United States.



Gemtuzumab Ozogamicin (Mylotarg®)

International Nonproprietary Name (INN)HCP WebsitePrescribing InformationNDC
Gemtuzumab OzogamicinHCP WebsitePrescribing InformationNDC 0008-4510-01
Brand NameEHR ResourcesDrug DescriptionFDA
Mylotarg®   First: 2000

Second: 2017

Marketing LicensePatient InformationDrug MapEMA
Pfizer / Wyeth Pharmaceuticals   
 Access Data/Patient AssistantCondition 
  Acute myeloid leukemia 
Additional info   
Gemtuzumab Ozogamicin (Mylotarg®; Pfizer) is indicated for the treatment of newly diagnosed CD33-positive acute myeloid leukemia (AML) in adults, and relapsed or refractory CD33-positive AML in adults and pediatric patients 2 years and older.



Inotuzumab Ozogamicin (Besponsa®)

International Nonproprietary Name (INN)HCP WebsitePrescribing InformationNDC
Inotuzumab ozogamicin Prescribing InformationNDC 0008-0100-01
Brand NameEHR ResourcesDrug DescriptionFDA
Besponsa®  2017
Marketing LicensePatient InformationDrug MapEMA
Pfizer / Wyeth Pharmaceuticals   
 Access Data/Patient AssistantCondition 
  Hematological malignancies 
Additional info   
Inotuzumab ozogamicin (Besponsa®; Pfizer) is the first and only FDA-approved CD22-directed antibody-drug conjugate indicated for the treatment of adults with relapsed or refractory B-cell precursor ALL.



Loncastuximab tesirine-lpyl (Zynlonta®)

International Nonproprietary Name (INN)HCP WebsitePrescribing InformationNDC
Loncastuximab tesirine-lpyl Prescribing InformationNDC 79952-110-01
Brand NameEHR ResourcesDrug DescriptionFDA
Zynlonta®  2021
Marketing LicensePatient InformationDrug MapEMA
ADC Therapeutics   
 Access Data/Patient AssistantCondition 
  Diffuse large B-cell lymphoma 
Additional info   
Loncastuximab tesirine-lpyl (Zynlonta®), a CD-19 ADC with a PBD payload developed by ADC Therapeutics, is indicated for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, DLBCL arising from low-grade lymphoma, and high-grade B-cell lymphoma. Mechanism of Action Upon binding to CD19, Loncastuximab tesirine-lpyl  is internalized into the tumor cell and the PBD dimer cytotoxin is released into the cell. The PBD dimer—an alkylating agent—binds to the DNA minor groove and forms highly cytotoxic DNA interstrand crosslinks. DNA interstrand crosslinks subsequently induce tumor cell death1 This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).



Mirvetuximab Soravtansine-gynx (Elahere®)

International Nonproprietary Name (INN)HCP WebsitePrescribing InformationNDC
Mirvetuximab soravtansine-gynx Prescribing InformationNDC 72903-853-01
Brand NameEHR ResourcesDrug DescriptionFDA
Elahere®   
Marketing LicensePatient InformationDrug MapEMA
ImmunoGen   
 Access Data/Patient AssistantCondition 
    
Additional info   

Mirvetuximab soravtansine (Elahere®; previously known as IMGN853) is a first-in-class ADC comprising a folate receptor alpha (FRα)-binding antibody, cleavable linker, and the maytansinoid payload DM4, a potent tubulin-targeting agent to kill the targeted cancer cells.

The US Food and Drug Administration (FDA) granted accelerated approval for the treatment of adult patients with folate receptor alpha (FRα)-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens.

Mirvetuximab soravtansine was approved under FDA’s accelerated approval program based on objective response rate (ORR) and duration of response (DOR) data from the pivotal SORAYA trial. Continued approval may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Mirvetuximab soravtansine is a first-in-class ADC directed against FRα, a cell-surface protein highly expressed in ovarian cancer, and is the first FDA approved ADC for platinum-resistant disease.
History In June 2018, the FDA granted mirvetuximab Fast Track designation for the treatment of patients with medium to high FRα-positive platinum-resistant ovarian cancer who received at least one, but no more than three prior systemic treatment regimens, and for whom single-agent chemotherapy is appropriate as the next line of therapy. This designation is intended to facilitate the development and expedite the review of drugs to treat serious and life-threatening conditions.

In December 2019, the Company (ImmunoGen) announced that FDA advised that a new single-arm study in platinum-resistant ovarian cancer could support accelerated approval for mirvetuximab. Based on this guidance, the Company initiated SORAYA, a pivotal trial to evaluate mirvetuximab monotherapy in women with FRα-high platinum-resistant ovarian cancer who have been previously treated with bevacizumab (Avastin®; Genentech/Roche). Positive top-line data for SORAYA was announced in November 2021.

Confirmation studies ImmunoGen is concurrently enrolling MIRASOL, the Phase 3 randomized confirmatory study of mirvetuximab in patients with FRα-high platinum-resistant ovarian cancer who have been treated with up to three prior regimens. Mirvetuximab monotherapy is also being studied in later line platinum-sensitive ovarian cancer and in combination in both platinum-resistant and platinum-sensitive disease.
This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.



Polatuzumab Vedotin-piiq (Polivy™)

International Nonproprietary Name (INN)HCP WebsitePrescribing InformationNDC
Polatuzumab vedotin-piiq Prescribing InformationNDC 50242-103-01 NDC 50242-105-01
Brand NameEHR ResourcesDrug DescriptionFDA
Polivy™  2019
Marketing LicensePatient InformationDrug MapEMA
Genentech/Roche   
 Access Data/Patient AssistantCondition 
  Diffuse large B-cell lymphoma 
Additional info   
Polatuzumab vedotin-piiq (Polivy™; Genentech/Roche), in combination with bendamustine and a rituximab product, is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, after at least 2 prior therapies.

Accelerated approval was granted for this indication based on a complete response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Sacituzumab Govitecan-hziy (Trodelvy™

International Nonproprietary Name (INN)HCP WebsitePrescribing InformationNDC
Sacituzumab govitecan-hziy Prescribing InformationNDC 55135-132-01
Brand NameEHR ResourcesDrug DescriptionFDA
Trodelvy™  2020
Marketing LicensePatient InformationDrug MapEMA
Gilead Sciences   
 Access Data/Patient AssistantCondition 
  Triple-negative breast cancer 
Additional info   
Sacituzumab govitecan (sacituzumab govitecan-hziy; Trodelvy™; Immunomedics) is a Trop-2-directed antibody-drug conjugated, linking a Trop-2 targeting antibody to a topoisomerase I inhibitor (SN-38) for the treatment of solid tumors, including metastatic triple-negative breast cancer (mTNBC).[1] In April 2020, sacituzumab govitecan received accelerated approval from the U.S. Food and Drug Administration for the treatment of adult patients with metastatic triple-negative breast cancer (mTNBC) who have received at least two prior therapies for metastatic disease. Sacituzumab govitecan is undergoing phase III development for breast cancer in the United States and Europe, and phase II development for urothelial cancer. The drug is also being explored for brain metastases, glioblastoma, endometrial cancer, and prostate cancer.



Tisotumab vedotin-tftv (Tivdak® )

International Nonproprietary Name (INN)HCP WebsitePrescribing InformationNDC
Tisotumab vedotin-tftv Prescribing InformationNDC 51144-003-01
Brand NameEHR ResourcesDrug DescriptionFDA
Tivdak®  2021
Marketing LicensePatient InformationDrug MapEMA
Seagen / Genmab   
 Access Data/Patient AssistantCondition 
  Cervical cancer 
Additional info   
Tisotumab vedotin-tftv (Tivdak® ) is a tissue factor-directed antibody and microtubule inhibitor conjugate indicated for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.



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