Blood cancer drug Adcetris approved by FDA
pharmafile | August 24, 2011 | News story | Sales and Marketing | Adcetris, Cancer, Seattle Genetics, lymphoma
The FDA has approved Seattle Genetics’ blood cancer drug Adcetris for two forms of lymphoma.
Adcetris (brentuximab vedotin) can now be used to treat Hodgkin lymphoma and a rare lymphoma known as systemic anaplastic large cell lymphoma.
Specifically, the drug is for the treatment of patients with Hodgkin lymphoma (HL) after failure of autologous stem cell transplant, or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not candidates for the stem cell transplant.
It is also licensed to treat patients with systemic anaplastic large cell lymphoma (ALCL) after failure of at least one prior multi-agent chemotherapy regimen.
The approval makes Adcetris the first drug specifically indicated for ALCL and the first one approved for Hodgkin’s lymphoma since 1977.
Seattle Genetics released the price of the drug earlier this week and said Adcetris will cost $4,500 per vial.
In its clinical trials, patients on average received three vials per dose and between seven and nine doses per treatment, meaning the total price will vary from around $94,500 (£57,290) to $121,500 per patient, according to Reuters.
Clay Siegall, president and chief executive of Seattle Genetics, said he was hopeful the drug could gain further indications from the FDA.
“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.”
Owen O’Connor, director of the Division of Hematology and Medical Oncology at NYU Cancer Institute, said: “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.”
The effectiveness of Adcetris in patients with HL was evaluated in a single clinical trial involving 102 patients.
Seventy-three percent of patients achieved either a complete or partial response to the treatment and on average, these patients responded to the therapy for 6.7 months.
The effectiveness of Adcetris in patients with systemic ALCL was evaluated in a single clinical trial in 58 patients.
Similar to the HL trial, the trial’s primary endpoint was objective response rate and of the patients receiving Adcetris for ALCL, 86% experienced either a complete or partial response and responded on average for 12.6 months.
The drug is being approved under the FDA’s accelerated approval programme, which allows the agency to approve a drug to treat a serious disease based on clinical data showing that the drug has an effect on a surrogate endpoint that is reasonably likely to predict a clinical benefit to patients.
This programme is designed to provide patients with earlier access to promising new drugs, but Seattle Genetics will be required to submit additional clinical information after approval to confirm the drug’s clinical benefit.
About 9,000 Americans a year are diagnosed with Hodgkin’s lymphoma and around 3,000 with ALCL.
Adcetris is an antibody-drug conjugate that combines an antibody and drug, allowing the antibody to direct the drug to a target on lymphoma cells known as CD30.
Ben Adams
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