FDA Approved Antibody Drug Conjugates
.png)
Published: September 2025
Owing to the increased prevalence of cancer and heightened emphasis towards targeted therapy, the pharmaceutical industry is increasingly shifting focus towards the development of antibody drug conjugates (ADCs). These innovative biotherapeutics represent a revolutionary approach in cancer treatment by combining the specificity of monoclonal antibodies with the potent cell-killing ability of cytotoxic drugs.
We analyzed over 760 therapy programs (involving ~615 ADCs) that are either approved or under development for the treatment of various oncological and non- oncological disorders. In this article, discover five recently FDA approved antibody drug conjugates along with the information on their developers
Over the years, there has been a significant rise in the preference for ADCs by both the patients and healthcare professionals. This can be attributed to the limitations associated with traditional chemotherapy, such as lack of specificity, high systemic toxicity, and variable therapeutic responses. However, despite the increasing preference for ADCs, pharmaceutical companies are facing several challenges to develop ADCs due to their complex structure comprising an antibody, linker, and ADC cytotoxic payloads and warheads. This complexity leads to manufacturing difficulties, formulation challenges, and potential immunogenic responses that can compromise the efficacy and safety of the drug. To address these challenges, various technology platforms are being developed to enable the formulation and production of stable, effective ADCs with improved therapeutic indices.
Further, ADC manufacturing and delivery systems have garnered significant attention within the pharmaceutical industry. This interest stems from their ability to provide targeted cancer therapy while minimizing damage to healthy cells. The ADC industry is rapidly evolving, with a focus on developing more effective targeting mechanisms designed to enhance therapeutic outcomes. Consequently, it has been observed that many pharmaceutical companies are directing their efforts towards developing next-generation ADCs with improved drug-to-antibody ratios, enhanced linker stability, and more potent payloads.
Roots Analysis has conducted an exhaustive study on Antibody Drug Conjugate Market featuring the current approved and under development therapies landscape, and future opportunities for the companies developing antibody drug conjugates (ADCs), over a span of 10 years.
Table of Contents
The list of five recently FDA approved antibody drug conjugates along with the information on their developers, initial approval year and target antigens are listed below (in reverse chronological order):
| S. No. | Drug Name | Developer Name | Initial Approval Year | Target Antigen |
| 1 | Emrelis (Telisotuzumab Vedotin) | AbbVie | 2025 | c-Met |
| 2 | Datroway (Datopotamab Deruxtecan) | AstraZeneca / Daiichi Sankyo | 2025 | TROP2 |
| 3 | Elahere (Mirvetuximab Soravtansine) | ImmunoGen / AbbVie | 2022 | FRα |
| 4 | Tivdak (Tisotumab Vedotin) | Pfizer | 2021 | Tissue Factor |
| 5 | Zynlonta (Loncastuximab Tesirine) | ADC Therapeutics | 2021 | CD19 |
Interested in exploring 750+ antibody drug conjugates therapy programs, 150+ ADC Developers and their recent initiatives?
Discover Below the Details on Five Recently FDA Approved Antibody Drug Conjugates
This article highlights the five recently FDA approved antibody drug conjugates to watch out for in this industry. It is essential to note that the selection of recently approved ADCs can differ substantially according to the defined criteria.
Emrelis, Which Specifically Targets the c-met Protein, Represents AbbVie’s Strategic Entry into Precision Lung Cancer Treatment
1. Emrelis
Emrelis (telisotuzumab vedotin) (developed by AbbVie) is a c-Met-directed antibody drug conjugate that received FDA accelerated approval in May 2025 for the treatment of non-small cell lung cancer. The ADC targets the c-Met protein, which is overexpressed in approximately 25% of patients with advanced EGFR wild-type, non-squamous NSCLC. It is worth mentioning that the drug utilizes a protease-cleavable linker to deliver the microtubule-disrupting agent MMAE directly to c-Met-expressing cancer cells.
Emrelis received FDA Breakthrough Therapy Designation in December 2021 and represents the first and only treatment approved for previously treated advanced NSCLC patients with high c-Met protein overexpression.
Emrelis: Drug Profile
| Parameters | Details |
| Name of the Drug | Emrelis |
| Other Names / Identifiers | Telisotuzumab vedotin, ABBV-399 |
| Target Disease Indication | Lung cancer |
| Target Antigen | c-MET |
| Linker | Valine-citrulline |
| Type of Payload | Auristatin |
| Type of Therapy | Monotherapy |
Developer’s Details
The details on the year of establishment, number of employees and headquarters of AbbVie have been listed below:
AbbVie: Company Details
| Key Parameters | Description |
| Company Logo |  |
| Year of Establishment | 2013 |
| Number of Employees | 10,001+ |
| Headquarters |  |
To know more about Emrelis and other antibody drug conjugates developed by AbbVie, access our full report.
Datroway, Developed Using Daiichi Sankyo’s Innovative DXd Platform, Aims to Provide Enhanced Efficacy in trop2-positive Cancer
2. Datroway
Datroway (developed by Daiichi Sankyo and AstraZeneca) is a TROP2-directed ADC, received FDA approval in January 2025, for the treatment of hormone receptor-positive, HER2-negative breast cancer. The drug binds to TROP2 (trophoblast cell surface antigen 2) expressing tumors, undergoing internalization to release a cytotoxic topoisomerase I inhibitor that leads to DNA damage and apoptotic cell death. The drug generated significant clinical benefit in the TROPION-Breast01 phase 3 trial, showing a 37% reduction in the risk of disease progression or death versus chemotherapy.
It is worth mentioning that Datroway jointly developed and commercialized globally by Daiichi Sankyo and AstraZeneca, with the exception of Japan where Daiichi Sankyo retains exclusive rights. It is worth mentioning that Daiichi Sankyo is responsible for the manufacturing and supply of Datopotamab Deruxtecan. In June 2025, Datroway received a second USFDA approval for EGFR-mutated non-small cell lung cancer, making it the first TROP2-directed therapy approved for NSCLC in the United States. Under the partnership agreement, AstraZeneca paid Daiichi Sankyo USD 1 billion upfront, with additional milestone payments of USD 45 million for the recent approval.
Datroway: Drug Profile
| Parameters | Details |
| Name of the Drug | Datroway |
| Other Names / Identifiers | Datopotamab deruxtecan, DS-1062 |
| Target Disease Indication | Breast cancer, Lung cancer |
| Target Antigen | TROP-2 |
| Linker | Peptide linker |
| Type of Payload | Topoisomerase I inhibitor |
| Type of Therapy | Monotherapy |
Developer’s Details
The details on the year of establishment, number of employees and headquarters of AstraZeneca and Daiichi Sankyo have been listed below:
AstraZeneca & Daiichi Sankyo: Companies Details
| Key Parameters | Description 1 | Description 2 |
| Company Logo |  |
 |
| Year of Establishment | 1999 | 2007 |
| Number of Employees | 10,001+ | 10,001+ |
| Headquarters |  |
 |
To know more about Datroway and other antibody drug conjugates developed by AstraZeneca and / or Daiichi Sankyo, access our full report.
With Over USD 479 Million in 2024 Sales, Elahere has Strengthened AbbVie’s position in Gynecological Cancer
3. Elahere
Elahere (developed by AbbVie) is folate receptor alpha (FRα) antibody drug conjugate received accelerated approval by USFDA in November 2022, and subsequently received full approval on March 2024, for the treatment of FRα-positive, platinum-resistant epithelial ovarian cancer. Elahere is first FRα-directed ADC and utilizes a cleavable linker to deliver the microtubule inhibitor DM4 specifically to folate receptor-positive cancer cell. It is worth mentioning that in FY 2024 the drug generated revenues of USD 479 million, representing strong market penetration for target indication.
Elahere: Drug Profile
| Parameters | Details |
| Name of the Drug | Elahere |
| Other Names / Identifiers | Mirvetuximab soravtansine, IMGN853 |
| Target Disease Indication | Ovarian cancer, Fallopian tube cancer, Peritoneal cancer |
| Target Antigen | FOLR1 (Folate receptor alpha) |
| Linker | N-Succinimidyl 4-(2-pyridyldithio)-2-sulfobutanoate (Sulfo-SPDB) |
| Type of Payload | Maytansinoid |
| Type of Therapy | Monotherapy |
Developer’s Details
The details on the year of establishment, number of employees and headquarters of AbbVie have been listed below:
AbbVie: Company Details
| Key Parameters | Description |
| Company Logo | |
| Year of Establishment | 2013 |
| Number of Employees | 10,001+ |
| Headquarters | |
To know more about Elahere and other antibody drug conjugates developed by AbbVie, access our full report.
Through its USD 43 Billion Acquisition of Seagen, Pfizer has Strengthened its Leadership in Tissue-Directed ADC Innovation with the Addition of Tivdak
4. Tivdak
Tivdak (developed by Seagen (a Pfizer-acquired company)) a tissue factor-directed ADC, received FDA accelerated approval on September 20, 2021, and full approval on April 29, 2024, for recurrent or metastatic cervical cancer. The drug works by targeting tissue factors, a protein expressed on cervical cancer cells that promote tumor growth, angiogenesis, and metastases. The drug generated revenues of USD 131 million in 2024, establishing it as an important treatment option for patients with limited therapeutic alternatives.
It is worth mentioning that in In December 2023, Pfizer closed its USD 43 billion acquisition of Seagen, gaining full ownership of the company’s four marketed cancer drugs including Tivdak.
Tivdak: Drug Profile
| Parameters | Details |
| Name of the Drug | Tivdak |
| Other Names / Identifiers | HuMax-TF, Tisotumab vedotin |
| Target Disease Indication | Cervical cancer |
| Target Antigen | Tissue factor |
| Linker | Valine-citrulline |
| Type of Payload | Auristatin |
| Type of Therapy | Monotherapy |
Developer’s Details
The details on the year of establishment, number of employees and headquarters of Pfizer have been listed below:
Pfizer: Company Details
| Key Parameters | Description |
| Company Logo |  |
| Year of Establishment | 1849 |
| Number of Employees | 10,001+ |
| Headquarters |  |
To know more about Tivdak and other antibody drug conjugates developed by Pfizer, access our full report.
Zynlonta, with its Unique DNA Cross-Linking Mechanism, Contributes to the Evolving Standards of Targeted Therapy in Hematologic Malignancies
5. Zynlonta
Zynlonta (developed by ADC Therapeutics) is CD19-directed ADC received accelerated approval on April 2021, for relapsed or refractory large B-cell lymphoma. The drug utilizes a unique pyrrolobenzodiazepine (PBD) dimer payload that causes DNA cross-linking and represents the first CD19-targeted antibody drug conjugate approved as monotherapy. The drug generated USD 69.1 million in 2023.
Zynlonta: Drug Profile
| Parameters | Details |
| Name of the Drug | Zynlonta |
| Other Names / Identifiers | Loncastuximab tesirine, ADCT-402 |
| Target Disease Indication | B-cell lymphoma |
| Target Antigen | CD19 |
| Linker | Valine-alanine |
| Type of Payload | SG3199 |
| Type of Therapy | Monotherapy |
Developer’s Details
The details on the year of establishment, number of employees and headquarters of ADC Therapeutics have been listed below:
ADC Therapeutics: Company Details
| Key Parameters | Description |
| Company Logo |  |
| Year of Establishment | 2011 |
| Number of Employees | 201-500 |
| Headquarters |  |
To know more about Zynlonta and other antibody drug conjugates developed by ADC Therapeutics, access our full report.
What About the Other Approved Antibody Drug Conjugates?
The above presentation features recently FDA approved antibody drug conjugates from a pool of all the antibody drug conjugates that we have compiled. If you're interested, you can download the Sample Report on this topic by Roots Analysis. For personalized assistance in identifying the most relevant solutions based on your specific criteria, please don't hesitate to reach out to us at sales@rootsanalysis.com.
Sources
- https://news.abbvie.com/2024-09-27-AbbVie-Submits-Biologics-License-Application-to-the-FDA-for-Telisotuzumab-Vedotin-Teliso-V-in-Previously-Treated-Non-Small-Cell-Lung-Cancer
- https://clinicaltrials.gov/ct2/show/NCT03311477?term=ABBV+399&draw=2&rank=1
- https://www.adcreview.com/drugmap/telisotuzumab-vedotin-abbv-399/
- https://www.fiercepharma.com/pharma/astrazeneca-daiichi-sankyos-adc-datroway-scores-its-second-fda-approval
- https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761394s000lbl.pdf
- https://www.astrazeneca.com/media-centre/press-releases/2025/datopotamab-deruxtecan-granted-priority-review-in-the-us-for-patients-with-previously-treated-advanced-egfr-mutated-non-small-cell-lung-cancer.html
- https://www.adcreview.com/drugmap/ds-1062-trop2-adc-datopotamab-deruxtecan-ds-1062/
- https://www.abbvie.com/science/pipeline.html
- https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761310s000lbl.pdf
- https://ascopubs.org/doi/abs/10.1200/JCO.2019.37.15_suppl.3009
- https://www.adcreview.com/drugmap/mirvetuximab-soravtansine-imgn-853/
- https://news.abbvie.com/2024-06-06-AbbVie-Announces-Positive-Topline-Results-from-Phase-2-PICCOLO-Trial-Evaluating-Mirvetuximab-Soravtansine-ELAHERE-R-for-High-Folate-Receptor-Alpha-FR-Expressing-Platinum-Sensitive-Ovarian-Cancer
- https://cdn.pfizer.com/pfizercom/product-pipeline/Q4%202024%20Pipeline%20Update_vFINAL3.pdf
- https://ir.genmab.com/static-files/7045fbcb-be89-4b9c-9dac-ac596d6bb543
- https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761196s000lbl.pdf
- https://www.adcreview.com/drugmap/loncastuximab-tesirine-adct-402/