ADC Therapeutics Announces FDA’s Acceptance of its Biologics License Application
LONDON & BOSTON – 4BIO Capital (“4BIO” or “the Group”), an international venture capital firm focused solely on the advanced therapies sector, notes that portfolio company ADC Therapeutics SA (“ADC” or the “Company”), a late clinical stage oncology-focused biotechnology company, today announced the acceptance of its Biologics License Application (“BLA”), by the U.S. Food and Drug Administration (“FDA”), for the Company’s proprietary loncastuximab tesirine (“Lonca”) medication, which targets the treatment of relapsed or refractory diffuse large B-cell lymphoma (“DLBCL”). The FDA has granted Lonca a priority review status and has set a Prescription Drug User Fee Act (“PDUFA”) target date of May 21, 2021.
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 48.3% (70/145 patients) and a complete response rate of 24.1% (35/145 patients). The tolerability profile was manageable with the most common grade ≥3 treatment-emergent adverse events in ≥10% of patients being: neutropenia (25.5%) with low incidence of febrile neutropenia (3.4%), thrombocytopenia (17.9%), GGT increase (16.6%) and anaemia (10.3%).
Dmitry Kuzmin, Managing Partner at 4BIO Capital, commented: “The FDA’s acceptance of ADC’s BLA submission is a great accomplishment for the company, for the next generation ADC class and for DLBCL patients who are in desperate need of new treatment options. 4BIO has been an investor since 2015 and we look forward to the PDUFA meeting in May.”
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