SAN DIEGO—Seattle Genetics CEO Clay Siegall remembers reading about the first FDA approvals under the agency’s new Real Time Oncology Review pilot, secured 24 and 28 days after filing.
“When I read that initially, I was like, ‘my, that is lightspeed,’” he said in an interview at the American Society of Hematology annual meeting. Little did he know that his company would soon put those timelines to shame.
It took just 11 days for Seattle Genetics’ Adcetris regimen to snag its approval in patients with newly diagnosed peripheral T-cell lymphoma, with the FDA doling out an OK in the middle of last month. And “for a veteran of decades of working in biotech, I am still pinching myself. Wow,” Siegall said.
It all started when company staffers, who were at the time waiting for data from the phase 3 Echelon-2 study, noticed the RTOR announcement on the FDA website. “We said if our data are really, really good, maybe we should contact FDA and see what this is about,” Siegall recalled.
And after the trial returned numbers that were “very strong,” the company did just that. Regulators made clear that they’d be coming back frequently with questions and comments, and those started rolling in on a daily basis.
“We started getting … ‘can you chart this, can you do this graph, what do you mean by this data, tell us about this data, and what about that,” Siegall said. And on each letter from the FDA gave a short—very short—time to respond, usually 24 hours.
“I think once or twice it said 48 hours. Might have been on a weekend,” Siegall said.
The company worked 24/7—every evening, every weekend—to connect with the FDA. Siegall described the agency as “incredibly engaged.”
“It was just breathtaking to have gone through that, to see what happens and see the FDA with their questions at their finest,” he said. “[Y]ou could just see all the cylinders working along and just moving forward.”
The result? Seattle Genetics submitted its supplemental new drug application for Adcetris in five weeks, which was “an all-time, blistering-fast record for us,” Siegall said, noting that most submissions take about three months. Ultimately, the Adcetris cocktail picked up a go-ahead between six to eight months earlier than the company had expected, helping it get out to more patients.
While multiple drugs have already locked up the FDA’s favor under the new pathway since this summer—Novartis' Kisqali became the first to do so in July, and Merck's Keytruda followed in August—Siegall doesn’t expect to see it happen every time.
“My hunch is this will be reserved for really the best data,” he said.
His advice for companies that do want to go for it? Make sure you have strong enough regulatory and clinical teams “to address the FDA’s questions and comments in an expedient way.”
“It’s not just getting it back quick, it’s getting it back quick and in depth and fully answered with all the relevant data,” he noted.