- The Food and Drug Administration took just two weeks to approve Seattle Genetics' application to expand the use of its cancer drug Adcetris, quickly clearing the label expansion through a pilot program that allows the regulator to review data before an official submission.
- Adcetris, an antibody drug conjugate co-developed with Takeda, is now OK'd for first-line treatment of peripheral T-cell lymphoma, making it the first treatment specifically approved for newly diagnosed patients with the rare, fast-growing blood cancer.
- This appears to be the second time the FDA has granted a label extension via the Real-Time Oncology Review program, following a positive decision in July on Novartis' Kisqali. Typically, regulatory review for drug applications takes between six and 10 months, although the agency can move faster in certain circumstances.
The FDA set up its Oncology Center of Excellence in January 2017 in an attempt to streamline and improve regulatory review for cancer drugs — one of several revamps undertaken by the agency in oncology.
So far, those efforts have resulted in a steady stream of new cancer drugs. Of the 46 new drugs OK'd last year, 12 were in oncology and a similar number have been cleared for market so far this year
The Real-Time Oncology Review program gives the FDA the opportunity to begin analyzing clinical data earlier, before formal submission of a supplemental New Drug Application or Biologics License Application for already approved drugs.
Once a drugmaker obtains and finalizes results from a pivotal study, the FDA can begin its work, providing feedback before the full application crosses regulators' desks. For now, the pilot only covers supplemental applications.
Novartis' breast cancer drug Kisqali (ribociclib) became the first to go through the process, winning an expedited OK in a certain type of metastatic breast cancer.
The Oncology Center of Excellence has also developed an assessment aid pilot project. The FDA sends the applicant an assessment aid template during the Investigational New Drug stage. The company fills in the template, and returns it at the same time as its original or supplemental NDA or BLA submission, helping to focus the review and make applications more consistent.
Approval of the new indication for Adcetris (brentuximab vedotin) was supported by data from the Phase 3 ECHELON-2 study, which compared Seattle Genetics' drug plus chemotherapy to a standard CHOP chemo regimen.
With the approval, Adcetris is now approved across six different indications, including first-line treatment of classical Hodgkin's lymphoma.