Congratulations. A great technology, the antibody-drug conjugate (ADC) technology, which is perfected by the two biotech firms, Seattle Genetics (SGEN) and ImmunoGen (IMGN) has yielded the first approved drug. Yes, the FDA has granted accelerated approval of Adcentris™ (brentuximab vedotin) developed by Seattle Genetics (SGEN) for two indications:
(1) 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) Systemic anaplastic large cell lymphoma (ALCL) after failure of at least one prior multi-agent chemotherapy regimen. The indications for Adcentris™ are based on response rate.
Adcentris™ 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 Seattle Genetics expects to make the drug available to patients next week.
As Clay B. Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics said, “The approval of Adcentris is a result of more than a decade of research and development by talented scientists and physicians. Indeed, the technology was very difficult to perfect. From among many firms who tried to develop it, only Seattle Genetics and ImmunoGen have perfected it and filled their pipelines with products based on it.
Seattle Genretics is determined to continued clinical investigation of Adcentris through a broad development program for CD30-positive malignancies, including confirmatory trials in front-line Hodgkin and T-cell lymphomas that the firm has planned in consultation with the FDA.
In clinical trials, Adcentris has caused durable complete remission rate. The drug’s approval represents a major advancement in the care of these patients.
Adcentris (brentuximab vedotin) is an antibody-drug conjugate (ADC). It comprises 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 tumor 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.
For further information on trials, safety, and other drug information go to Seattle Genetics Website: http://www.seattlegenetics.com
The technology that contributed to the successful outcome of Adcentris (brentuximab vedotin), i.e., antibody-drug conjugate (ADC), is expected to bring more effective and safer drugs for diseases that has yet to find adequately safe and effective remedies. This is good news for both Seattle Genetics and ImmunoGen.
We long Seattle Genetics and ImmunoGen