UPDATED: FDA pins approval on Seattle Genetics' cancer drug Adcetris

Seattle Genetics ($SGEN) has crossed the finish line. The FDA has granted the biotech an accelerated approval for Adcetris to treat Hodgkin's lymphoma and anaplastic large cell lymphoma. While it's an expected victory, the approval is an important first for the Bothell, WA-based developer.

With the accelerated approval, Seattle Genetics will have to complete further studies to show the drug provides clinical benefits to patients. The FDA has given the drug a market green light based largely on a pair of successful single-arm studies, and there's no evidence the drug impacts survival of cancer patients. Still, Adcetris--which is an antibody linked to an anti-cancer toxin--is the first drug approved for Hodgkin's lymphoma since 1977 and the first ever treatment cleared for anaplastic large cell lymphoma, according to the FDA.

"Bringing a new product to the market is a significant milestone for Seattle Genetics in fulfilling its mission to improve the lives of people with cancer," company CEO Clay Siegall said. "The approval of Adcetris is a result of more than a decade of research and development by talented scientists and physicians."

The company plans to start making the drug available to patients this week, wasting no time to get the product out the door. As Xconomy's Luke Timmerman reported on Friday, the 14-year-old biotech has run up a deficit of more than $546 million during its years of development. And, apparently, the steep cost of the company's R&D comes with a steep price for its first drug. This morning, on a call with analysts, the biotech revealed that Adcetris would cost $13,500 per dose, which could add up to $108,000 per patient for the drug based on the number of doses patients took in clinical trials, Timmerman reports today.

A new test for the drug will be to see how healthcare payers react to its price tag. In several recent cases, biotechs have struggled with new product launches and disappointed investors in the process. Dendreon's ($DNDN) stock price fell off a cliff early this month when the biotech revealed lackluster sales figures for its recently introduced prostate-cancer vaccine Provenge, which costs $93,000 per patient.

"We... remain concerned that investor fear of owning new product launches may be a drag on [Seattle Genetics'] shares until Adcetris justifies otherwise," Cory Kasimov, an analyst at J.P. Morgan, wrote in a note to investors on Friday.

- here's the company's release
- and the FDA release
- see Timmerman's reports from today and Friday

Editor's Note: This story was updated on Aug. 22 with pricing data on Adcetris.