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Orphan status in Europe for lymphoma drug Zynlonta

The ADC Therapeutics antibody-drug conjugate is licensed to treat patients with a common form of non-Hodgkin lymphoma.

Lausanne-based biotech ADC Therapeutics has received orphan drug designation in the European Union for its antibody-drug conjugate Zynlonta four months after approval by the Food and Drug Administration.

Zynlonta (loncastuximab tesirine-lpyl) is licensed to treat patients with diffuse large B-cell lymphoma (DLBCL), a common form of non-Hodgkin lymphoma.

“This orphan drug designation recognises the significant unmet need in patients with diffuse large B-cell lymphoma in the European Union,” said Joseph Camardo, ADC’s chief medical officer. “We are committed to providing global access to Zynlonta for as many patients as may benefit.”

Orphan drug designation in the EU aims to encourage the development of drugs that may provide significant benefit to patients suffering from rare, life-threatening diseases and offers ten years of marketing exclusivity as well as providing incentives.

Zynlonta is a CD19-directed antibody drug conjugate (ADC) that binds with a CD19-expressing cell and causes tumour cell death.

The FDA granted the drug accelerated approval in May for use in adult patients with relapsed or refractory (r/r) large B-cell lymphoma after two or more lines of systemic therapy.

The FDA approval was based on data from LOTIS-2, a phase 2 multinational, single-arm clinical trial of Zynlonta involving 145 patients with r/r DLBCL following two or more prior lines of systemic therapy, including “a broad spectrum of heavily pre-treated patients with very difficult to treat disease”, says ADC.

About 60% of patients with DLBCL are cured with regimens such as rituximab, cyclophosphamide, adriamycin, vincristine, and prednisone (R-CHOP), however, most patients who relapse or do not respond to therapy will die from the disease.

ZYNLONTA is also in late-stage clinical trials in combination with other agents and is being evaluated as a monotherapy.

ADC Therapeutics is also testing its ADC Cami (camidanlumab tesirine) 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 August, ADC entered into a financing agreement with healthcare investment firm HealthCare Royalty Partners. In exchange for a 7% royalty on worldwide net sales and licensing revenue from Zynlonta and Cami, ADC will receive $225m upfront, $75m following the first commercial sale of Zynlonta in Europe and $25m on a near-term commercial milestone for Zynlonta.

Article by
Hugh Gosling

15th September 2021

From: Regulatory

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