The Food and Drug Administration (FDA) expedited the approval of Adcetris (brentuximab vedotin) in combination with chemotherapy for certain patients with peripheral T-cell lymphoma (PTCL).
The Food and Drug Administration (FDA) approved Adcetris (brentuximab vedotin) in combination with chemotherapy for certain patients with peripheral T-cell lymphoma (PTCL) – marking the first FDA approval for newly diagnosed patients with PTCL. Not to mention, it was a part of a new review program (the Real-Time Oncology Review) that expedites the FDA’s speed in approving drugs.
“The current standard of care for initial treatment of peripheral T-cell lymphoma is multi-agent chemotherapy. That treatment has not significantly changed in decades and is too often unsuccessful in leading to long-term remissions, underscoring the need for new treatments,” Steven Horwitz, M.D., medical oncologist at Memorial Sloan Kettering Cancer Center in New York, said in a statement.
The approval, which follows a breakthrough therapy designation
just yesterday, was based on results from the phase 3 ECHELON-2 trial, which showed that patients on Adcetris had statistically significant improvements in progression-free survival (PFS) – the primary endpoint of the study – as well as secondary endpoints, like overall survival (OS). Full data from the ECHELON-2 trial will be presented at the American Society of Hematology (ASH) Annual Meeting in December.
The trial, which included more than 450 patients, was a multi-center, randomized, double-blind placebo-controlled trial that compared Adcetris plus CHP (cyclophosphamide, doxorubicin, prednisone) to CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone) as a frontline treatment for patients with CD30-expressing PTCL.
“The ECHELON-2 clinical trial demonstrated ADCETRIS plus CHP was superior to the current standard of care, CHOP, for both progression-free survival and all other key secondary endpoints, including, most importantly, overall survival. With this approval, clinicians have the opportunity to transform the way newly diagnosed CD30-expressing PTCL patients are treated,” Horwitz said.
The agent’s manufacturer, Seattle Genetics, filed for a Real-Time Oncology Review, which led to the drug’s speedier approval.
“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,” said Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products, in a statement.
“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,” he added. “(Real-Time Oncology Review) allowed the FDA to approve this indication within two weeks of the completed application’s submission.”
The most common side effects for the Adcetris combination included peripheral neuropathy, nausea and vomiting, diarrhea, low white blood cell counts, fatigue, mouth sores, constipation, hair loss, fever and low red blood cell counts.
More serious side effects included anaphylaxis, neuropathy, fever, gastrointestinal complications, tumor lysis syndrome, skin reactions and lung effects. Women who are pregnant or breast feeding are advised not to take Adcetris.