Seattle Genetics' Adcetris scores first-line lymphoma nod, setting up 'biggest opportunity' yet

FDA
The FDA green-lighted Seattle Genetics' Adcetris Tuesday in first-line advanced lymphoma patients. (FDA)

Seattle Genetics officially has the first-line Adcetris nod in advanced classical Hodgkin lymphoma that it’s been gunning for. Now, it’ll be up to the company to capitalize on what CEO Clay Siegall has called “the biggest market opportunity that we have yet looked at.”

The FDA gave Adcetris the go-ahead Tuesday, green-lighting the drug, in tandem with chemo, to treat adults with stage III or IV forms of the disease.

RELATED: Seattle Genetics CEO sees a big new Adcetris market, but one analyst has some doubts

Free Webinar

Striving for Zero in Quality & Manufacturing

Pharmaceutical and medical device manufacturers strive towards a culture of zero – zero hazards, zero defects, and zero waste. This webinar will discuss the role that content management plays in pharmaceutical manufacturing to help companies reach the goal of zero in Quality and Manufacturing.

That label is more favorable than at least one analyst predicted; back in December, SunTrust’s Yatin Suneja wrote to clients that Adcetris was “likely to be limited to younger (age <60 years) patients and/or those with Stage IV disease,” restrictions that would have narrowed “the total addressable patient population and hence the market potential of Adcetris,” he said.

It’s also one that Siegall and co. approve of. “I believe that if FDA goes ahead and approves this with a label that says ‘advanced Hodgkin lymphoma,’ I think that that would be very good because it puts it in the doctors’ hands to decide on their patients,” the skipper said in a December interview at the American Society of Hematology annual meeting.

RELATED: Can Adcetris' narrow beat in new trial win a new FDA nod? Seattle Genetics, Takeda hope so

With the approval in hand, Seattle Genetics expects to see Adcetris eventually become a billion-dollar drug in Canada and the U.S. alone—and last year, the company beefed up its sales force by about 30% to prepare for the possibility. At this point, “we think with the U.S. and Canada, we have it covered well,” Siegall said, pointing to “very high market penetration” that he believes bodes well for the new indication.

“We feel very good about how we’ve launched and continue to sell and market Adcetris,” he added.

Patient numbers aren’t huge in Hodgkin lymphoma; only 8,260 U.S. patients were diagnosed with the disease last year, according to the FDA.

But one point in Seattle Genetics’ favor? It won’t have a slew of new competitors to contend with. The new Adcetris approval marks an upgrade to advanced Hodgkin lymphoma treatment regimens that have been around for more than 40 years.

Suggested Articles

The cleaning procedures are so poor at a Zydus Cadila plant in India that the FDA says a sampling found 10 different cross-contaminated products.

Oklahoma politicians contend J&J should be on the line for future abatement costs even after a $572 million verdict, but J&J sees things differently.

Abbott helmsman Miles White, who oversaw the spinoffs of AbbVie and Hospira, will step down as CEO after 21 years at the top job.