FDA grants speedy expanded approval for Seattle Genetics' Adcetris in first-line peripheral T-cell lymphoma

Seattle Genetics announced Friday that Adcetris (brentuximab vedotin) in combination with chemotherapy gained expanded US approval to include adults with previously untreated systemic anaplastic large cell lymphoma (sALCL) or other CD30-expressing peripheral T-cell lymphomas (PTCL), including angioimmunoblastic T-cell lymphoma and PTCL not otherwise specified. The company noted that its application was approved less than two weeks after submission under the FDA's Real-Time Oncology Review pilot programme. 

Richard Pazdur, acting director of the FDA's Office of Hematology and Oncology Products, explained that "the Real-Time Oncology Review programme 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." 

The new approval was backed by data from the Phase III ECHELON-2 trial. The study compared Adcetris plus CHP chemotherapy consisting of cyclophosphamide, doxorubicin and prednisone, with the CHOP regimen comprised of cyclophosphamide, doxorubicin, vincristine and prednisone. According to Seattle Genetics, ECHELON-2 demonstrated that combination treatment with Adcetris plus CHP was superior to CHOP for progression-free survival (PFS), cutting the risk of progression, death or receipt of subsequent anticancer chemotherapy to treat residual or progressive disease by 29 percent.

Further, the company said Adcetris plus CHP was superior on the key secondary endpoint of overall survival compared to CHOP, adding that significance was also reached for all other key secondary endpoints, including PFS in patients with sALCL. Specifically, Seattle Genetics reported that the complete remission rate was 68 percent versus 56 percent in the Adcetris combination and CHOP groups, respectively, while the objective response rates were 83 percent versus 72 percent. Results will be presented next month at the American Society of Hematology(ASH) annual meeting.

The FDA awarded breakthrough therapy status to Adcetris for patients with treatment-naïve PTCL earlier this month. The therapy, which Seattle Genetics co-develops with Takeda, has been cleared in the US for a number of indications, most recently gaining approval for use in certain patients with advanced Hodgkin's lymphoma. 

For related analysis, see ViewPoints: Failure to launch for Adcetris? See also ViewPoints: Adcetris the usurper expands its lymphoma kingdom.

To read more Top Story articles, click here.