After receiving approval for a breakthrough medicine, ADC Therapeutics SA (NYSE: ADCT) is soaring today, up 15.70% to trade at $3.68 at the last check in early trading.
What does ADCT receive permission for?
The European Commission (EC) has given conditional marketing authorization for the use of ZYNLONTA (loncastuximab tesirine) for treating refractory or relapsed diffuse large B-cell lymphoma (DLBCL), according to ADC Therapeutics (ADCT) and Swedish Orphan Biovitrum AB (Sobi). The clearance comes after the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency provided a favorable opinion in September (EMA). After the transfer of the marketing authorization is complete, Sobi anticipates starting the introduction of ZYNLONTA.
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This authorization represents a significant step forward in ADC Therapeutics’ mission to take ZYNLONTA across the globe. For patients with DLBCL throughout Europe, ADCT hopes that ZYNLONTA will be able to assist meet a crucial unmet need. Based on results from LOTIS-2, a significant Phase 2 international, single-arm clinical study of ZYNLONTA for treating patients who have relapsed or refractory DLBCL after two or even more previous lines of systemic therapy, the approval was made.
The first CD19-targeted antibody-drug conjugate (ADC), ZYNLONTA received expedited clearance from the U.S. Food and Drug Administration (FDA) in April 2021 as a particular procedure for grownup patients with relapsed or refractory DLBCL following two or more lines of systemic therapy.
The development and marketing of ZYNLONTA across all solid tumor and hematologic purposes in Europe and a few other foreign markets will be done under an exclusive licensing arrangement between ADCT and Sobi that was first disclosed earlier this year. According to the provisions of the contract, Sobi would pay ADCT $50 million as a milestone payment when the EC approves ZYNLONTA.
How will ADCT proceed with the approval?
Additionally, ADC Therapeutics (ADCT) and Mitsubishi Tanabe Pharma Corporation (MTPC) have an exclusive licensing agreement for the development and marketing of ZYNLONTA in Japan for all solid tumor and hematologic indications. A joint venture between Overland Pharmaceuticals and ADCT called Overland ADCT BioPharma is also attempting to develop and market ZYNLONTA in Singapore and Greater China. An integral and essential critical Phase 2 clinical study of ZYNLONTA in patients with recurrent or refractory DLBCL is now being conducted in China by Overland ADCT BioPharma.
