WASHINGTON (AP) — A panel of federal cancer experts has
unanimously voted to grant accelerated approval to Seattle Genetics’ innovative
chemotherapy drug for two types of rare blood cancer.
All 10 members of the Food and Drug Administration’s
oncology drug panel voted in favor of approving the drug based on a study of
each in patients with Hodgkin’s disease and a type of lymphoma. Regular drug
approval normally requires two late-stage trials for each indication. The FDA
is not required to follow the group’s advice, though it usually does.
“This drug has extremely exciting activity and is a
great example of the kind of drug that should go ahead with accelerated
approval,” said panel chair Dr. Wyndham Wilson of the National Cancer
The company has submitted its drug, called Adcetris, as a
treatment for patients whose cancer has not responded to other drugs or has
Hodgkin’s disease and systemic anaplastic large cell
lymphoma are both rare cancers that affect fewer than 5,000 new U.S. patients
each year. The panel voted unanimously in two separate votes that that the drug
should be made available for patients with the diseases.
Under accelerated approval, drug companies must conduct
follow-up studies to confirm that their drugs live up to their initial promise.
Seattle Genetics will have to negotiate the size and structure of these
confirmatory studies with FDA officials.
Adcetris uses a targeted antibody designed to deliver chemotherapy
directly to cancerous tumor cells, sparing healthy cells.
If the drug is ultimately approved, Seattle Genetics will
market it in the U.S. and Canada while
Takeda Group will hold marketing rights for the rest of the world.
Trading in shares of Seattle Genetics Inc., based in Bothell, Wash.,
was halted Thursday due to the pending panel vote.