Adcetris FDA approval : Seattle Genetics has secured new approval from the US Food and Drug Administration (FDA) for its monoclonal antibody Adcetris (brentuximab vedotin), which is in combination with CHP chemotherapy (cyclophosphamide, doxorubicin, prednisone) for the treatment of certain types of peripheral T-cell lymphoma (PTCL).
Adcetris FDA approval for PTCL in combination with CHP chemotherapy
The new Adcetris FDA approval is for the treatment of systemic anaplastic large cell lymphoma (sALCL) that was previously untreated or other CD30-expressing peripheral T-cell lymphomas in adults. Included in these are angioimmunoblastic T-cell lymphoma and PTC that are not specified otherwise.
FDA’s approval for Adcetris plus CHP chemotherapy combination has been driven by the results of the phase 3 clinical trial called ECHELON-2. The late-stage trial, which featured 452 patients with certain PTCLs, assessed Adcetris and CHP combination to CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone) in the first line setting.
In the Adcetris arm, the progression-free survival, which is the amount of time a patient stays alive without the cancer growing, was significantly longer at an average of 48 months, in comparison to 21 months in the CHOP arm.
Along with it, the overall survival and overall response rates were also significantly better in the patient arm treated with the Adcetris chemotherapy combination.
Clay Siegall – President and CEO of Seattle Genetics, commenting on the new Adcetris FDA approval, said: “By participating in the FDA’s Real-Time Oncology Review process and working closely with the FDA, we are now able to make the Adcetris regimen available to previously untreated patients with CD30-expressing PTCL in an unprecedented less than two weeks after submission of our supplemental BLA.
“The ECHELON-2 clinical trial demonstrated Adcetris plus CHP results in a superior outcome for patients when compared to current standard of care, CHOP. We want to thank the patients, physicians and their staff who participated in the ECHELON-2 trial, which supported this FDA approval.”
According to the FDA, peripheral T-cell lymphomas are unique, rapidly-growing non-Hodgkin lymphomas that are formed from white blood cells called T-cells, which usually spread quickly throughout the body and are difficult to treat.
Commenting on the new Adcetris FDA approval, Richard Pazdur – director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products, said: “The Real-Time Oncology Review (RTOR) program allows the FDA to access key data prior to the official submission of the application allowing the review team to begin their review earlier and communicate with the sponsor prior to the application’s actual submission.
“When the sponsor submits the completed application, the review team will already be familiar with the data and be able to conduct a more efficient, timely and thorough review. RTOR allowed the FDA to approve this indication within two weeks of the completed application’s submission.”
Adcetris has been designed to bind to the CD30 protein found on certain cancer cells, was approved previously by the FDA for the treatment of adult patients with previously untreated stage III or IV classical Hodgkin lymphoma (cHL), cHL after relapse, cHL after stem cell transplant when a patient is highly prone to relapse or progression, systemic ALCL following failure of other treatment, and primary cutaneous ALCL or CD30-expressing mycosis fungoides after failing to respond to other treatment.