FDA Announces First Approval for Newly Diagnosed PTCL

FDA Announces First Approval for Newly Diagnosed PTCL

NOVEMBER 16, 2018

The FDA approved a new indication for brentuximab vedotin injection (Adcetris, Seattle Genetics). The drug is now approved to treat previously untreated systemic anaplastic large cell lymphoma (ALCL) and other CD30-expressing peripheral T-cell lymphomas (PTCLs) in combination with chemotherapy.

This is the first FDA approval for the treatment of newly diagnosed PTCL, according to the FDA. The new indication was approved less than two weeks after submission through the agency’s Real-Time Oncology Review (RTOR), a pilot program launched in July 2018 to expedite the availability of potentially lifesaving cancer treatments.

RTOR is granted to treatments likely to demonstrate substantial improvements over available therapy; brentuximab vedotin injection is only the fourth treatment to receive an RTOR.

The FDA based its approval on the double-blind, randomized, multicenter, phase 3 ECHELON-2 clinical trial, which included 452 patients with certain PTCLs who received either brentuximab vedotin injection plus chemotherapy or a standard CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone) chemotherapy regimen as first-line treatment. Progression-free survival was significantly longer in the brentuximab vedotin injection arm (median, 48 months) than in the CHOP arm (21 months) (hazard ratio, 0.71; P=0.01).

Overall survival and overall response rates also were significantly improved in the brentuximab vedotin injection arm.

The most common side effects in the brentuximab vedotin injection arm included peripheral neuropathy, nausea and vomiting, diarrhea, leukopenia, fatigue, mouth sores, constipation, hair loss, fever and anemia.

Brentuximab vedotin injection is a monoclonal antibody that binds to the CD30 protein found on some cancer cells. The drug was previously approved by the FDA to treat adult patients with previously untreated stage III or IV classic Hodgkin lymphoma (cHL), cHL after relapse, cHL after stem cell transplant when a patient is at a high risk for relapse or progression, systemic ALCL after failure of other treatment, and primary cutaneous ALCL or CD30-expressing mycosis fungoides after failure of other treatment.

Health care providers should monitor patients treated with brentuximab vedotin injection for infusion reactions, anaphylaxis, neuropathy, fever, gastrointestinal complications and infections, according to the FDA. Patients also should be monitored for tumor lysis syndrome, serious skin reactions, pulmonary toxicity and hepatotoxicity.

Women who are pregnant or breastfeeding should not take brentuximab vedotin injection because it may cause harm to a developing fetus or newborn baby, the FDA warned. The prescribing information for the drug includes a boxed warning to advise health care professionals and patients about the risk for fatal or life-threatening progressive multifocal leukoencephalopathy in treated patients.

The full data from the ECHELON-2 trial are slated to be released in an oral presentation at the 2018 annual meeting of the American Society of Hematology, in San Diego, on Dec. 3 at 6:15 p.m. PT.

Article via Clinical Oncology News.