MedPath

Loncastuximab tesirine

Generic Name
Loncastuximab tesirine
Brand Names
Zynlonta
Drug Type
Biotech
Chemical Formula
-
CAS Number
1879918-31-6
Unique Ingredient Identifier
7K5O7P6QIU
Background

Relapsed and refractory B-cell acute lymphoblastic leukemia (B-ALL) are a therapeutic challenge for patients who have undergone prior systemic therapies with limited success. Prognosis is poor and more effective therapies are needed to treat relapsed/refractory cases and improve survival. On April 23 2021, the Food and Drug Administration granted accelerated approval for the antibody-drug conjugate, loncastuximab tesirine-lpyl, also known as Zynlonta. Zylonta also received approval in the EU on December 22, 2022. This therapy was developed by ADC Therapeutics and its accelerated approval for relapsed or refractory B-cell lymphoma is based on promising results from the LOTIS-2 clinical trial.

Indication

Loncastuximab tesirine is indicated for the treatment of adults with relapsed or refractory large B-cell lymphoma who have undergone two or more prior 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. The above indication is approved under accelerated FDA approval following the results of clinical studies. Continued approval is dependant upon the results of confirmatory clinical trials. In Europe, Loncastuximab tesirine is approved for treatment of both adult and pediatric patients aged 12 years old or older for relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL) after two or more lines of systemic therapy.

Associated Conditions
Refractory Diffuse Large B Cell Lymphoma (DLBCL), Refractory Diffuse Large B-Cell Lymphoma, Not Otherwise Specified, Relapsed Diffuse Large B-cell Lymphoma (DLBCL), Refractory High Grade B-cell Lymphoma (HGBCL), Relapsed Diffuse large B-cell lymphoma NOS, Relapsed High Grade B-cell Lymphoma (HGBCL)
Associated Therapies
-
globenewswire.com
·

Antibody Drug Conjugate Market Industry Trends and

The global antibody drug conjugate market is projected to grow from USD 7.72 billion to USD 23.3 billion by 2035, driven by advancements in antibody engineering and clinical trial successes. Over 280 ADCs are approved or in clinical studies, with 250+ in early development. Key segments include breast cancer, solid tumors, and HER-2 antigen. North America leads in market share, while Asia-Pacific shows higher growth potential.
benzinga.com
·

ADC Therapeutics Faces Competitive Oncology Market But Analyst Sees 100% Upside - Here's Why

Stephens analyst initiates coverage on ADC Therapeutics (ADCT), highlighting Zynlonta's potential despite market challenges. The analyst projects Zynlonta's peak revenue at $110 million by 2032 in the third-line setting and $172 million in second-line DLBCL, supported by LOTIS-5 and LOTIS-7 trial results. ADCT's broad ADC pipeline offers additional growth opportunities.
marketwatch.com
·

Cancer Antibody Drug Conjugates Market, Drugs Approval, Price, Sales & Clinical Trials

Antibody drug conjugates (ADCs) are a transformative class in cancer treatment, with 16 approved products and sales exceeding $10B in 2023. The market is expected to surpass $50B by 2030, driven by over 500 ADCs in clinical trials. Key players include Enhertu, Kadcyla, and Padcev, with significant sales in breast and lung cancers. The US and China lead the market, supported by robust R&D and regulatory environments.
globenewswire.com
·

Cancer Antibody Drug Conjugates Market, Drugs Approval & Clinical Trials Report 2024

The Cancer Antibody Drug Conjugates Market report highlights the transformative potential of ADCs in cancer treatment, with 16 approved products and sales exceeding $10B in 2023. The market is projected to surpass $50B by 2030, driven by ongoing clinical trials and increased R&D efforts. Key players include Padcev, Kadcyla, and Enhertu, with significant development activity in lung and breast cancer. The market is led by the US and China, with major pharmaceutical companies driving innovation.
morningstar.com
·

Swedish Orphan Biovitrum Has Built a Narrow Moat Around Hematology and Immunology Products

Since 2016, Sobi has expanded from a European specialty pharmaceutical firm to include US markets and new therapeutic areas in immunology and hematology through successful drug launches and acquisitions, warranting a narrow moat rating.
© Copyright 2025. All Rights Reserved by MedPath