ADC Therapeutics Announces FDA Accepts Biologics License Application and Grants Priority Review for Loncastuximab Tesirine for Treatment of Relapsed or Refractory Diffuse Large B-cell Lymphoma
ADC Therapeutics SA (NYSE: ADCT) announced the FDA's acceptance of its Biologics License Application (BLA) for loncastuximab tesirine (Lonca), targeting relapsed or refractory diffuse large B-cell lymphoma (DLBCL), with a priority review status. A PDUFA target date is set for May 21, 2021. The BLA is based on the LOTIS 2 trial, reporting a 48.3% overall response rate among 145 patients. Common severe adverse events included neutropenia (25.5%) and thrombocytopenia (17.9%). Long-term efficacy and safety data are pending further studies.
- FDA accepted BLA for loncastuximab tesirine, showing significant progress in treatment options.
- Priority review status granted by FDA indicates potential expedited approval.
- LOTIS 2 trial demonstrates a 48.3% overall response rate, exceeding target endpoints.
- PDUFA target date set for May 21, 2021; any delays could impact market sentiment.
- Safety profile shows substantial adverse events, including 25.5% neutropenia and 17.9% thrombocytopenia.
LAUSANNE, Switzerland--(BUSINESS WIRE)--ADC Therapeutics SA (NYSE: ADCT), a late clinical-stage oncology-focused biotechnology company pioneering the development and commercialization of highly potent and targeted antibody drug conjugates (ADCs) for patients with hematological malignancies and solid tumors, today announced that the U.S. Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for loncastuximab tesirine (Lonca) for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and granted priority review status. The FDA has set a Prescription Drug User Fee Act (“PDUFA”) target date of May 21, 2021.
“The FDA’s acceptance of our BLA and granting of priority review for Lonca is a tremendous accomplishment that brings ADC Therapeutics one step closer to being able to offer patients with relapsed or refractory DLBCL a greatly needed new treatment option in 2021,” said Chris Martin, Chief Executive Officer of ADC Therapeutics. “We look forward to working with the FDA during its review of our BLA submission for Lonca. Our organization remains focused on robust planning for a successful launch next year.”
The BLA submission is based on data from LOTIS 2, the pivotal Phase 2 multi-center, open-label, single-arm clinical trial evaluating the efficacy and safety of Lonca in patients with relapsed or refractory DLBCL following two or more lines of prior therapy. In June 2020, the Company presented maturing data from LOTIS 2 at the virtual 25th Congress of the European Hematology Association. As of the April 6th cutoff date, Lonca demonstrated an overall response rate of
Data from subgroup analyses of LOTIS 2 will be presented in a poster (abstract #1183) at the upcoming 62nd American Society for Hematology (ASH) Annual Meeting on Saturday, December 5, 2020.
About Loncastuximab Tesirine (Lonca)
Loncastuximab tesirine (Lonca, formerly ADCT-402) is an antibody drug conjugate (ADC) composed of a humanized monoclonal antibody directed against human CD19 and conjugated through a linker to a pyrrolobenzodiazepine (PBD) dimer cytotoxin. Once bound to a CD19-expressing cell, Lonca is designed to be internalized by the cell, following which the warhead is released. The warhead is designed to bind irreversibly to DNA to create highly potent interstrand cross-links that block DNA strand separation, thus disrupting essential DNA metabolic processes such as replication and ultimately resulting in cell death. CD19 is a clinically validated target for the treatment of B-cell malignancies.
Lonca, the Company’s lead product candidate, has been evaluated in a 145-patient pivotal Phase 2 clinical trial for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL) that showed a
About ADC Therapeutics
ADC Therapeutics SA (NYSE: ADCT) is a late clinical-stage oncology-focused biotechnology company pioneering the development and commercialization of highly potent and targeted antibody drug conjugates (ADCs) for patients with hematological malignancies and solid tumors. The Company develops ADCs by applying its decades of experience in this field and using next-generation pyrrolobenzodiazepine (PBD) technology to which ADC Therapeutics has proprietary rights for its targets. Strategic target selection for PBD-based ADCs and substantial investment in early clinical development have enabled ADC Therapeutics to build a deep clinical and research pipeline of therapies for the treatment of hematological and solid tumor cancers. The Company has multiple PBD-based ADCs in ongoing clinical trials, ranging from first in human to confirmatory Phase 3 clinical trials, in the USA and Europe, and numerous preclinical ADCs in development.
Camidanlumab tesirine (Cami, formerly ADCT-301), the Company’s second lead product candidate, is being evaluated in a 100-patient pivotal Phase 2 clinical trial for the treatment of relapsed or refractory Hodgkin lymphoma (HL) after having shown in a Phase 1 clinical trial an
ADC Therapeutics is based in Lausanne (Biopôle), Switzerland and has operations in London, the San Francisco Bay Area and New Jersey. For more information, please visit https://adctherapeutics.com/ and follow the Company on Twitter and LinkedIn.
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