New drug for lymphoma! CD19 Target Antibody Association Drug (ADC) loncastuximab tesirine (Lonca) is under FDA priority review!

November 21, 2020 // -- ADC Therapeutics SA is a Late Clinical Swiss biotechnology company dedicated to the development and commercialization of highly effective targeted antibody drug couples (ADCs) for the treatment of blood malignancies and solid tumors.
recently, the company announced that the U.S. Food and Drug Administration (FDA) has accepted Loncastuximab tesirine (Lonca, formerly known as ADCT-402) bio-product licensing application (BLA) and granted priority review of the drug used to treat recurring or recurring diffuse large B-cell lymphoma (DLBCL).
FDA has designated a target action date for the Prescription Drug User Charge Act (PUDFA) as May 21, 2021.
Loncastuximab tesirine (Lonca) is an ADC therapy that targets CD19 and is made up of an human-based anti-human CD19 monoclonal antibody coupled with pyrrolobenzodiazepine (PBD) djurgic cell toxins via a connector.
Once it binds to cells that express CD19, Lonca is internalized by the cells and then releases a cytotoxin that irreversibly binds to DNA, creating strong interclocking that prevents DNA chain separation, disrupting the necessary DNA metabolic processes such as replication, which eventually leads to cell death.
CD19 is a well-established target for the treatment of B-cell malignancies. Chris Martin, CHIEF executive of
ADC Therapeutics, said: "The FDA's acceptance of our BLA and granting Lonca priority review is a huge achievement that takes us one step closer to providing a much-needed new treatment for patients with relapsed or resuscable DLBCL in 2021.
look forward to working with the FDA during its review of the BLA.
our organization remains focused on developing a strong plan for next year's successful release.
lonca BLA, the antibody drug coupled-PBD djumer technology, based on data from the key Phase 2 LOTIS 2 study.
this is a multi-center, open-label, one-arm clinical trial that evaluates the efficacy and safety of Lonca's treatment of patients with relapsed or incurable DLBCL who have previously received at least 2 system therapies.
In June 2020, the company presented mature data from LOTIS 2 at the 25th European Society of Hematology (EHA) Virtual Conference: as of April 6, 2020, 145 patients had been admitted to the group, with a median of three previous system therapies.
results showed that Lonca's objective mitigation rate (ORR) was 48.3% (70/145 cases) and its full mitigation rate (CR) was 24.1% (35/145 cases).
study, Lonca's tolerance was generally controllable, with the most common adverse events (TEAE) occurring during ≥10% of patients≥ 5 per cent), fever-neutral granulocytosis (3.4 per cent), plateiasis (17.9 per cent), elevated GGT (16.6 per cent) and anemia (10.3 per cent).
also launched LOTIS 5, a validated Phase 3 clinical trial of Lonca's combination with lytoxidan, to support a complementary BLA that uses Lonca as a second-line therapy for relapsed or refractic DLBCL.
origin: ADC Therapeutics Announces FDA Accepts Biologics License application and Grants Priority Review for Loncastuximab Tesirine for Treatment of Relapsed or Refractory Diff Large B-cell Lymphoma