FDA approves Adcetris to treat patients with high-risk Hodgkin lymphoma

It is estimated that as many as 65,000 patients worldwide are diagnosed with Hodgkin's lymphoma (HL) per year, and about 30% of patients fail after initial treatment (first-line combination chemotherapy). The standard protocol for these patients is Rescue therapies, followed by auto-HSCT, and about half of patients undergoing a relapse after stem cell transplantation require additional treatment options to improve their disease-free survival. Adcetris then became the only consolidation treatment currently approved by the FDA, which will help HL patients to maintain remission after stem cell transplantation.

Adcetris is an antibody-conjugated drug (ADC) conjugated by a monoclonal antibody that targets the CD30 protein and a microtubule disrupter (monomethyl auristatin E, Mmae) via a protease-sensitive crosslinker. CD30 protein is a clear marker of classical Hodgkin lymphoma (HL) and systemic anaplastic large cell lymphoma (sALCL), and Auristatin E blocks cell division by inhibiting the polymerization of tubulin. Adcetris is stably present in the blood and releases MMAE after being internalized by CD30-positive tumor cells.

The approval of new indications for Adcetris is based on data from a Phase III AETHERA study. The study involved 329 patients with relapsed or exacerbated HL, of whom 165 received Adcetris and 164 received placebo. Data from this study have also been submitted to the European Medicines Agency (EMA) and Health Canada.

Some analysts predicted that the new indications approved will not only increase Adcetris' market share, but will also allow patients to stay on for longer periods of time, further stimulating sales growth. Antibody-drug conjugate (ADC) is one of the hot spots in the pharmaceutical industry in recent years. ADC drugs use specific linkers to link antibodies to small molecule cytotoxic drugs, and their major components include antibodies, linkers and small molecule cytotoxic drugs (SMs). Antibody molecules mainly play a role in targeted ADC delivery, and small molecule drugs exert their effects. However, some antibodies have anti-tumor pharmacodynamic effects at the same time, such as synergistic effects of ado-trastuzumab and maitansine (maytansine) in Kadcyla.

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