FDA Approved Radioimmunotherapies

Novel antibody therapies represent a rapidly evolving segment within the biopharmaceutical industry, offering innovative approaches to the treatment of a wide range of diseases. These therapies encompass various classes of antibodies designed to kill or inhibit disease-causing agents by specifically targeting antigens present on the surface of affected cells. By leveraging the precision of antibody-antigen interactions, novel antibody therapies have demonstrated significant potential in improving patient outcomes, particularly in areas such as cancer biologics, autoimmune disorders, and infectious diseases.

We analyzed over 165 next generation antibody therapeutics that are either approved or under development for the treatment of various disorders. In this article, discover FDA approved as well as Phase III radioimmunoconjugates, along with the information on their developers.

Recent advances in antibody engineering have enabled the development of innovative antibody formats with improved therapeutic efficacy and specificity. These advancements enable the selective targeting of diseased cells while minimizing off-target effects on healthy tissues. Roots Analysis has conducted an exhaustive study on Next Generation Antibody Therapeutics Market featuring the current market landscape and future opportunity for the companies engaged in novel antibody therapies market, over a span of next 10 years.

Table of Contents

S. No.	Drug Name	Developer Name	Current Status	Target Indication
1	Licartin	Chengdu Huasun Biotechnology	Marketed	Unresectable Hepatocellular Carcinoma
2	Iomab-B	Actinium Pharmaceuticals	Late-Stage	Acute Myeloid Leukemia
3	TLX 591	Telix Pharmaceuticals	Late-Stage	Prostate Cancer

Interested in exploring all 165+ next generation antibodies, 55+ developers and their recent initiatives?

Discover Below the Details on late stage / FDA approved radioimmunotherapies

Let us dive deep into the details of the late stage / FDA approved radioimmunotherapies.

Licartin, is the only Radioisotope Immunoconjugate that has been Commercialized to Treat the Patients suffering from Unresectable Hepatocellular Carcinoma

1. Licartin

Licartin (also known as 131I metuximab), is an I-131 based radioimmunotherapy, which received Chinese State FDA approval for the treatment of hepatocellular carcinoma.

Licartin Drug Profile

Parameters	Details
Drug Name	Licartin / 131I metuximab
Type of Radio Isotope	131-I
Target Antigen	Hepatocellular cancer (HCC)-associated antigen HAb18G/CD147
Type of Molecule / Modality	Monoclonal Antibody
Target Disease Indication	Hepatocellular Carcinoma
Route of Administration	Intravenous

Company Overview

The details on the year of establishment and headquarters of Chengdu Huasun Biotechnology have been listed below:

Chengdu Huasun Biotechnology: Company Details

Key Parameters	Description
Company Logo
Year of Establishment	2005
Headquarters

To know more about Licartin and other radioimmunoconjugates, access our full report.

Iomab-B received Orphan Drug Designation from FDA as well as European Medical Agency for the treatment of patients with Acute Myeloid Leukemia

2. Iomab-B

Iomab-B, is I-131 based drug, which is currently in phase III for the treatment of acute myeloid leukemia. Post the rejection of the BLA application in 2024, the USFDA recommended the developers to conduct the evaluation of the allogeneic bone marrow transplant using the candidate and reduced-intensity conditioning regimen consisting of fludarabine and total-body irradiation vs allogeneic BMT using the regimmen, including cyclophosphamide plus fludarabine and total-body irradiation.

Iomab-B Drug Profile

Parameters	Details
Drug Name	Iomab-B
Type of Radio Isotope	131-I
Target Antigen	CD45
Type of Molecule / Modality	Monoclonal Antibody
Target Disease Indication	Acute Myeloid Leukemia
Route of Administration	Intravenous

Company Overview

The details on the year of establishment, number of employees and headquarters of Actinium Pharmaceuticals have been listed below:

Actinium Pharmaceuticals: Company Details

Key Parameters	Description
Company Logo
Year of Establishment	2000
Number of Employees	11-50
Headquarters

To know more about Iomab-B and other radioimmunoconjugates, access our full report.

TLX 591, developed by Australian based company, is likely to be Approved in 2029 and reach its Peak Sales by 2033

3. TLX 591

TLX 591 (lutetium (177Lu) rosopatamab tetraxetan) is 177-Lu based radioimmunotherapy, which is currently in phase III for the development of prostate cancer. In December 2025, the developer announced the dosing of the first patient in the part 2 (randomized treatment expansion) of ProstACT Phase III trial. In this trial, the PSMA targeted radio ADC therapy is administered along with standard of care (abiraterone, enzalutamide or docetaxel) v/s standard of care alone.

TLX 591 Drug Profile

Parameters	Details
Drug Name	TLX 591
Type of Radio Isotope	177-Lu
Target Antigen	PSMA (Prostate Specific Membrane Antigens)
Type of Molecule / Modality	Monoclonal Antibody
Target Disease Indication	Prostate Cancer
Route of Administration	Intravenous

Company Overview

The details on the year of establishment, number of employees and headquarters of Telix Pharmaceuticals have been listed below:

Telix Pharmaceuticals: Company Details

Key Parameters	Description
Company Logo
Year of Establishment	2015
Number of Employees	51-200
Headquarters

To know more about TLX 591 and other radioimmunoconjugates, access our full report.

What About the Other Next Generation Antibodies?

The above presentation features FDA approved radio immunotherapies and therapies in late stages of development. 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:

1. https://clinicaltrials.gov/study/NCT00829465
2. https://clinicaltrials.gov/study/NCT02665065
3. https://www.actiniumpharma.com/product-pipeline
4. https://www.clinicaltrials.gov/study/NCT04876651
5. https://www.targetedonc.com/view/fda-rejects-iomab-b-bla-application-requests-new-randomized-study
6. https://telixpharma.com/pipeline/
7. https://telixpharma.com/news-views/prostact-global-phase-3-update-first-patient-dosed-in-randomized-treatment-expansion-part-1-readout-plans-confirmed/