As expected, regulators in the USA have given the green light in two indications to Seattle Genetics’ lymphoma treatment Adcetris.
Following a unanimous recommendation from its Oncologic Drugs Advisory Committee last month, the US Food and Drug Administration has approved Adcetris (brentuximab vedotin) for patients with relapsed and refractory Hodgkin lymphoma and patients with systemic anaplastic large cell lymphoma (ALCL). Seattle Genetics noted that the first-in-class treatment, a CD30-directed antibody-drug conjugate, is the first drug to be approved by the FDA for Hodgkin lymphoma in more than 30 years.
Specifically, Adcentris got the thumbs-up for to treat Hodgkin lymphoma patients 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. Patients with ALCL can use the drug after failure of at least one chemotherapy.
The FDA has granted accelerated approval to Adcetris, for which Takeda holds the rights outside North Amercia. This means Seattle Genetics needs to conduct follow-up studies to confirm the effectiveness and safety of the treatment and chief executive Clay Siegall said "we are committed to continued clinical investigation".
News of the approval has gone down well with patients and Hildy Dillon, of the USA's Leukemia & Lymphoma Society said "this is a great advance for patients battling both of these diseases.
She added that "these are both considered very curable diseases but there is a population of patients from both diseases for whom treatment has not been effective." Hodgkin lymphoma has an 86% survival rate and ALCL has an 80% cure rate but for those people "who don't respond well these can be very difficult cancers to cure".