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
Reference:  KADCYLA Prescribing Information. Genentech, Inc. April 2016
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.
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.
Reference:  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.
Reference:  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 complete response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
ADC Review, Journal of Antibody-drug Conjugates (ISSN 2327-0152) is an international peer-reviewed publication designed to serve the needs of a diverse community of individuals including academia, life sciences, pharma, research, clinicians and physicians. Along with regulatory affairs, we also cover government authorities and representatives from payers to policy makers.