For decades, patients with newly diagnosed peripheral T-cell lymphoma (PTCL) have had only chemotherapy as a treatment option. That’s set to change with an FDA approval for Seattle Genetics’ Adcetris in certain types of PTCLs.
With a Friday approval in combination with chemotherapy, Adcetris is the first treatment for patients with newly diagnosed PTCL, according to the FDA. With the approval, "clinicians have the opportunity to transform the way newly diagnosed CD30-expressing PTCL patients are treated,” Memorial Sloan Kettering Cancer Center oncologist Steven Horwitz, M.D., said in a statement.
Adcetris won its latest nod through a new regulatory pathway called Real-Time Oncology Review. Under the program, FDA officials can review a drug's data before an official submission, leading to more interaction throughout the review process and faster approvals after an application. Back in July, Novartis' Kisqali became the first to snag an OK under the pathway, and Merck's Keytruda followed in August.
The Adcetris approval came only 2 weeks after Seattle Genetics completed its FDA application and 6 months earlier than expected, Leerink Research analyst Andrew Berens, M.D., wrote in a note. His team believes “uptake will be rapid given that only chemotherapy is available to treat this disease, unlike Hodgkin's lymphoma."
In a clinical trial of 452 patients with certain PTCLs, the Adcetris-chemo pairing staved off disease progression for a median 48 months, compared with 21 months for the chemo-only group.
Friday’s nod in certain PTCLs adds to Adcetris’ other indications, including certain types of classical Hodgkin lymphoma.
The Friday approval follows a March thumbs-up in advanced classical Hodgkin lymphoma, an indication where Seattle Genetics has now launched. The company believes its drug will become a blockbuster in the U.S., CEO Clay Siegall, Ph.D., said on a conference call last month. For 2018, Seattle Genetics projects $473 million to $478 million in Adcetris sales, which would represent about a 50% jump over last year.