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ADC Therapeutics Receives Orphan Drug Designation in Europe for ZYNLONTA®
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Rhea-AI Summary
ADC Therapeutics has received Orphan Drug Designation from the European Commission for ZYNLONTA®, a CD19-targeted antibody drug conjugate (ADC) aimed at treating diffuse large B-cell lymphoma (DLBCL). This designation highlights the significant unmet medical need within the EU for DLBCL patients. Should ZYNLONTA be approved, it will enjoy ten years of marketing exclusivity and various incentives. The FDA-approved ZYNLONTA has shown promising clinical trial results, with an overall response rate of 48.3% for patients after two or more lines of therapy.
Positive
Received Orphan Drug Designation for ZYNLONTA by the European Commission.
Potential for ten years of marketing exclusivity if approved.
Promising clinical trial results with a 48.3% overall response rate.
Negative
None.
LAUSANNE, Switzerland--(BUSINESS WIRE)--
ADC Therapeutics SA (NYSE: ADCT), a commercial-stage biotechnology company leading the development of novel antibody drug conjugates (ADCs) to treat hematological malignancies and solid tumors, today announced that the European Commission has granted Orphan Drug Designation to ZYNLONTA®, a CD19-targeted ADC, for the treatment of diffuse large B-cell lymphoma (DLBCL).
“This Orphan Drug Designation recognizes the significant unmet need in patients with diffuse large B-cell lymphoma in the European Union (EU),” said Joseph Camardo, MD, Senior Vice President and Chief Medical Officer of ADC Therapeutics. “We are committed to providing global access to ZYNLONTA for as many patients as may benefit. This designation is an important step in our collaboration with EMA for our marketing authorization in the EU.”
Orphan Drug Designation in the EU is granted by the European Commission based on a positive opinion issued by the EMA Committee for Orphan Medicinal Products (COMP). It is intended to encourage the development of drugs that may provide significant benefit to patients suffering from rare, life-threatening diseases. If approved for marketing, this designation will provide ten years of marketing exclusivity and also provide special incentives for sponsors, including eligibility for protocol assistance and possible exemptions or reductions in certain regulatory fees.
About ZYNLONTA® (loncastuximab tesirine-lpyl)
ZYNLONTA®is a CD19-directed antibody drug conjugate (ADC). Once bound to a CD19-expressing cell, ZYNLONTA is internalized by the cell, where enzymes release a pyrrolobenzodiazepine (PBD) payload. The potent payload binds to DNA minor groove with little distortion, remaining less visible to DNA repair mechanisms. This ultimately results in cell cycle arrest and tumor cell death. 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 therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS), DLBCL arising from low-grade lymphoma and also high-grade B-cell lymphoma. This indication is approved by the FDA under accelerated approval based on overall response rate and continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
The FDA approval was based on data from LOTIS-2, a large (n=145) Phase 2 multinational, single-arm clinical trial of ZYNLONTA for the treatment of adult patients with r/r DLBCL following two or more prior lines of systemic therapy. The trial included a broad spectrum of heavily pre-treated patients (median three prior lines of therapy) with very difficult to treat disease, including patients with high-grade B-cell lymphoma. The trial enrolled patients who did not respond to first-line therapy, patients refractory to all prior lines of therapy, patients with double/triple hit genetics and patients who had stem cell transplants and CAR-T therapy prior to their treatment with ZYNLONTA. Results from the trial demonstrated an overall response rate (ORR) of 48.3% (70/145 patients), which included a complete response (CR) rate of 24.1% (35/145 patients) and a partial response (PR) rate of 24.1% (35/145 patients). Patients had a median time to response of 1.3 months. At the most recent data cut-off for patients enrolled in the trial, the median duration of response (mDoR) was 13.4 months. In a pooled safety population the most common adverse reactions (≥20%) were thrombocytopenia, gamma-glutamyltransferase increased, neutropenia, anemia, hyperglycemia, transaminase elevation, fatigue, hypoalbuminemia, rash, edema, nausea and musculoskeletal pain. In LOTIS-2, the most common (≥10%) grade ≥3 treatment-emergent adverse events were neutropenia (26.2%), thrombocytopenia (17.9%), gamma-glutamyltransferase increased (17.2%) and anemia (10.3%).
ZYNLONTA is being evaluated in combination for earlier lines of therapy and as a monotherapy in other B-cell malignancies.
About ADC Therapeutics
ADC Therapeutics (NYSE: ADCT) is a commercial-stage biotechnology company improving the lives of cancer patients with its next-generation, targeted antibody drug conjugates (ADCs). The Company is advancing its proprietary PBD-based ADC technology to transform the treatment paradigm for patients with hematologic malignancies and solid tumors.
ADC Therapeutics’ CD19-directed ADC ZYNLONTA®(loncastuximab tesirine-lpyl) is approved by the FDA for the treatment of relapsed or refractory diffuse large B-cell lymphoma after two or more lines of systemic therapy. ZYNLONTA is also in late-stage clinical trials in combination with other agents. Cami (camidanlumab tesirine) is being evaluated in a late-stage clinical trial for relapsed or refractory Hodgkin lymphoma and in a Phase 1b clinical trial for various advanced solid tumors. In addition to ZYNLONTA and Cami, the Company has multiple PBD-based ADCs in ongoing clinical and preclinical development.
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.
ZYNLONTA® is a registered trademark of ADC Therapeutics SA.
What is the significance of the Orphan Drug Designation granted to ADCT for ZYNLONTA?
The Orphan Drug Designation highlights the unmet medical need for patients with diffuse large B-cell lymphoma in the EU and may provide marketing exclusivity and incentives.
What is the overall response rate of ZYNLONTA in clinical trials?
ZYNLONTA demonstrated an overall response rate of 48.3% in clinical trials for patients with relapsed or refractory large B-cell lymphoma.
How long of marketing exclusivity can ZYNLONTA receive if approved in the EU?
If approved, ZYNLONTA could receive ten years of marketing exclusivity in the European Union.
What types of tumors does ZYNLONTA target?
ZYNLONTA targets CD19-expressing cells and is used to treat diffuse large B-cell lymphoma.
