The US Food and Drug Administration (FDA) has approved ADC Therapeutics’ ZYNLONTA as a third-line therapy for patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL).
The CD19-targeted antibody drug conjugate (ADC) was granted accelerated approval by the US regulator based on overall response rate.
The approval also covers patients with DLBCL arising from low grade lymphoma and high-grade B-cell lymphoma.
“This is the first ever approval of a PBD based ADC,” noted Chris Martin, CEO, ADC Therapeutics, on a conference call about the regulatory development and commercial launch.
The Lausanne, Switzerland based biotech is now entering
FDA Approves Loncastuximab for Diffuse Large B-Cell Lymphomas medscape.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from medscape.com Daily Mail and Mail on Sunday newspapers.
Published: Apr 23, 2021
First and only CD19-targeted antibody drug conjugate (ADC) as a single-agent treatment for adult patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL)
ZYNLONTA addresses an unmet need across a broad population of third-line (3L)+ r/r patients, including patients with DLBCL not otherwise specified, DLBCL arising from low grade lymphoma and high-grade B-cell lymphoma
ZYNLONTA demonstrated 48.3% overall response rate, 24.1% complete response rate and durable responses in heavily pretreated patients in pivotal LOTIS-2 trial
Investor conference call and webcast to be held Friday, April 23
rd at 4 p.m. ET
LAUSANNE, Switzerland (BUSINESS WIRE) ADC Therapeutics SA (NYSE: ADCT) today announced that the U.S. Food and Drug Administration (FDA) has approved ZYNLONTA™ (loncastuximab tesirine-lpyl) for the treatment of adult patients with relapsed or refractory (r/r) large B-cell lymphoma after two or more lines of systemic
ADC Therapeutics Announces FDA Approval of ZYNLONTA™ (loncastuximab tesirine-lpyl) in Relapsed or Refractory Diffuse Large B-Cell Lymphoma streetinsider.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from streetinsider.com Daily Mail and Mail on Sunday newspapers.
email article
The FDA has granted accelerated approval to loncastuximab tesirine-lpyl (Zynlonta) for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL) in adults.
Loncastuximab tesirine is an antibody-drug conjugate (ADC), comprised of a humanized monoclonal antibody directed against human CD19 and conjugated through a linker to the pyrrolobenzodiazepine dimer cytotoxin.
Approval was based on response data from the single-arm phase II LOTIS-2 trial for the treatment of adults with relapsed or refractory DLBCL following two or more lines of systemic therapy.
Among 145 patients, the drug demonstrated an overall response rate of 48.3%, a complete response rate of 24.1%, and a partial response rate of 24.1%. Median time to response was 1.3 months, while the median duration of response for the 70 responders was 10.3 months (inclusive of patients who were censored).