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Resources for For Clinicians

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®)

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
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Reference: [1] KADCYLA Prescribing Information. Genentech, Inc. April 2016

Belantamab mafodotin (Blenrep™)

Belantamab mafodotin-blmf (Blenrep™) 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)

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Reference: [1] Prescribing Information. GSK Inc. 2020

Brentuximab Vedotin (Adcetris®)

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.
 
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References [1] ADCETRIS [Prescribing Information]. Bothell, WA: Seattle Genetics, Inc.; September 2016.

Enfortumab Vedotin-ejfv (Padcev™)

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.

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Reference: [1] Padcev™ Prescribing Information. Astellas 2019

Fam-trastuzumab deruxtecan-nxki (Enhertu®)

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.

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Reference: [1] Enhertu® Prescribing Information. Daiichi Sankyo and AstraZeneca), December 2019

Gemtuzumab Ozogamicin (Mylotarg®)

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.
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Reference: [1] MYLOTARG Prescribing Information. New York, NY: Pfizer Inc.

Inotuzumab Ozogamicin (Besponsa®)

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.
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Reference: [1] BESPONSA Prescribing Information. New York, NY: Pfizer Inc.

Polatuzumab Vedotin-piiq (Polivy™)

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.

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Reference: [1] POLIVY Prescribing Information. Genentech, Inc. June 2019

Sacituzumab Govitecan-hziy (Trodelvy™)

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.

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Reference: [1] TRODELVY™ Prescribing Information. Immunimedics, Inc. April 2020

 


Loncastuximab tesirine-lpyl (Zynlonta®)

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).

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Reference: [1] Zynlonta® Prescribing Information. ADC Therapeutics SA.

Tisotumab vedotin-tftv (Tivdak® )

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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Reference: [1] Tivdak® Prescribing Information. Seagen and Genmab.

Mirvetuximab Soravtansine-gynx (Elahere®)

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.

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Reference: [1] Tivdak® Prescribing Information. Seagen and Genmab.

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