Approval in 2 Weeks via FDA’s New Oncology Drugs Review

In In The News by Barbara Jacoby

By: Zosia Chustecka


One of the first new approvals to emerge from the US Food and Drug Administration’s (FDA’s) new process for reviewing oncology drugs took only 2 weeks from submission of the supplemental application to approval for the new indication.

The approval was for expanded use of brentuximab vedotin (Adcetris, Seattle Genetics).

The drug can now be used in combination with chemotherapy for adult patients with previously untreated systemic anaplastic large cell lymphoma (ALCL) or other CD30-expressing peripheral T-cell lymphomas (PTCL), including angioimmunoblastic T-cell lymphoma and PTCL not otherwise specified.

This is a new indication for the drug. The product, a monoclonal antibody directed against CD30, was already approved for classical Hodgkin lymphoma, systemic ALCL after failure of other treatment, and primary cutaneous ALCL or CD30-expressing mycosis fungoides after failure of other treatment.

This is the first FDA approval for treatment of newly diagnosed PTCL, the agency noted. The trial on which the approval was based was the first to show improved survival in the frontline setting.

The data come from the phase 3 ECHELON-2 clinical trial. The full results will be presented at the upcoming annual meeting of the American Society of Hematology, the company noted.

New Process

The new process, known as the Real-Time Oncology Review (RTOR) program, allows the agency to access key data prior to the official submission of the application, the FDA explained in a press release.

This allows the review team “to begin their review earlier and communicate with the sponsor prior to the application’s actual submission,” said Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products.

“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 continued.

In this case, the RTOR enabled the FDA to approve this indication within 2 weeks, he added.

The new process was launched in July. Brentuximab is the fourth approval to emerge from the RTOR, noted the manufacturer.

Fast-Growing Lymphoma

PTCLs are rare, fast-growing non-Hodgkin lymphomas that are difficult to treat, the FDA said.

Approval of the new indication was based on the ECHELON-2 clinical trial of 452 patients with certain PTCLs who received first-line therapy with either bretuximab plus chemotherapy or a standard chemotherapy (cyclophosphamide, doxorubicin, vincristine, and prednisone [CHOP]).

Progression-free survival was significantly longer (hazard ratio, 0.71; P = .01) in the brentuximab arm (median, 48 months, compared to 21 months with CHOP). Overall survival and overall response rates were also significantly better in the brentuximab arm, the agency noted.

The most common side effects of brentuximab plus chemotherapy were peripheral neuropathy, nausea and vomiting, diarrhea, neutropenia, fatigue, mouth sores, constipation, hair loss, fever, and anemia.

The FDA advises healthcare providers to monitor patients for infusion reactions, life-threatening allergic reactions (anaphylaxis), neuropathy, fever, gastrointestinal complications, and infections. Patients should also be monitored for tumor lysis syndrome, serious skin reactions, pulmonary toxicity, and hepatotoxicity. There is also a boxed warning about the risk for fatal or life-threatening infection of the brain (progressive multifocal leukoencephalopathy).