Seattle Genetics, Inc. announced that the US Food and Drug Administration (FDA) has granted accelerated approval of Adcetris (brentuximab vedotin) for two indications: (1) the treatment of patients with Hodgkin lymphoma after failure of autologous stem cell transplant (ASCT) or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not ASCT candidates, and (2) the treatment of patients with systemic anaplastic large cell lymphoma (ALCL) after failure of at least one prior multi-agent chemotherapy regimen.

The indications for Adcetris are based on response rate. There are no data available demonstrating improvement in patient-reported outcomes or survival with Adcetris. Adcetris is the first drug approved by the FDA for Hodgkin lymphoma in more than 30 years, and provides a new therapeutic alternative for Hodgkin lymphoma and systemic ALCL in these settings. Seattle Genetics expects to make Adcetris available to patients next week. Adcetris is an antibody-drug conjugate (ADC) directed to CD30.

"Bringing a new product to the market is a significant milestone for Seattle Genetics in fulfilling its mission to improve the lives of people with cancer," said Clay B. Siegall, Ph.D., president and chief executive officer of Seattle Genetics. "The approval of Adcetris is a result of more than a decade of research and development by talented scientists and physicians. The company has deep appreciation for the hundreds of patients who participated in Adcetris trials, and the passion and determination of the clinicians at sites around the world in investigating this first in a new class of targeted anticancer agents. We are committed to continued clinical investigation of Adcetris through a broad development programme for CD30-positive malignancies, including confirmatory trials in front-line Hodgkin and T-cell lymphomas that we have planned in consultation with the FDA."

"The marked single agent activity seen with Adcetris, including a high durable complete remission rate, offers an opportunity to improve the treatment paradigm of patients for whom the treatment is indicated," said Owen A. O'Connor, M.D., Ph.D., Professor, and Director, Division of Hematology and Medical Oncology at NYU Cancer Institute. "This approval represents a major advancement in the care of these patients."

Seattle Genetics also announced that it has established a patient assistance programme named SeaGen Secure that offers patients and providers access to Adcetris reimbursement support, benefit investigations and patient assistance programmes.

Adcetris (brentuximab vedotin) is an antibody-drug conjugate (ADC) comprising an anti-CD30 monoclonal antibody attached by a protease-cleavable linker to a microtubule disrupting agent, monomethyl auristatin E (MMAE), utilizing Seattle Genetics' proprietary technology. The ADC employs a linker system that is designed to be stable in the bloodstream but to release MMAE upon internalization into CD30-expressing tumour cells.

The Adcetris approvals were based on data from two open-label, single-arm clinical trials: a pivotal trial in Hodgkin lymphoma patients who relapsed after ASCT and a pivotal trial in relapsed systemic ALCL patients. The primary endpoint of both trials was overall response rate as assessed by an independent review facility.

In the pivotal Hodgkin lymphoma clinical trial, 102 patients were enrolled who had relapsed after ASCT. Data demonstrated that 73 per cent (95 per cent CI 65, 83) of patients achieved an objective response following treatment with Adcetris, including 32 per cent (95 per cent CI 23, 42) with complete remissions and 40 per cent with partial remissions (95 per cent CI 32, 49). The median duration of objective response was 6.7 months (95 per cent CI 4.0, 14.8; range 1.3 to 21.9+ months).

In the pivotal systemic ALCL clinical trial, 58 patients with relapsed disease were enrolled. These data demonstrated that 86 per cent (95 per cent CI 77, 95) of patients achieved an objective response following treatment with Adcetris, including 57 per cent with complete remissions (95 per cent CI 44, 70) and 29 per cent with partial remissions (95 per cent CI 18, 41). The median duration of objective response was 12.6 months (95 per cent CI 5.7, not estimable; range 0.1 to 15.9+ months).

Seattle Genetics is jointly developing Adcetris with Millennium: The Takeda Oncology Company. Under the terms of the collaboration agreement, Seattle Genetics has US and Canadian commercialization rights and the Takeda Group has rights to commercialize Adcetris in the rest of the world. Seattle Genetics and the Takeda Group are funding joint development costs for Adcetris on a 50:50 basis, except in Japan where the Takeda Group will be solely responsible for development costs.

Seattle Genetics is a biotechnology company focused on the development and commercialization of monoclonal antibody-based therapies for the treatment of cancer.