Seagen secures a speedy FDA review on Tukysa as Merck buyout talks reportedly stall
After rumors of stalled buyout talks between Merck and Seagen, perhaps a new Tukysa indication could reignite interest.
The FDA has granted Tukysa a priority review in combination with Genentech’s Herceptin for second-line HER2-positive metastatic colorectal cancer, the company revealed on Monday. The decision comes just a couple of months after Seagen uncorked the full Phase II results at ESMO, boasting a notable improvement in overall survival from the last readout.
The FDA is expected to make a decision on an accelerated approval by Jan. 19, Seagen said.
For the last few months, Merck has been rumored to be mulling a potential Seagen buyout, multiple news outlets have reported. Last month, however, unnamed sources told Bloomberg that the companies hadn’t agreed on a price. Merck acquired the rights to sell Tukysa outside the US, Canada and Europe back in 2020, along with a $1 billion equity stake.
It’s a turbulent time for Seagen, as it searches for a new CEO in the wake of co-founder Clay Siegall’s resignation earlier this year amid a domestic violence investigation. Siegall has denied the allegations. CMO Roger Dansey is filling in for him in the interim.
In July, though, Seagen celebrated some positive news that Tukysa and Herceptin induced a progression-free survival of 8.2 months and overall survival of 24.1 months in 117 colorectal cancer patients. While it’s difficult to compare data across trials, those figures appear to beat GSK’s Tykerb-Herceptin combo, which is often used in this setting and showed a 10.6-month overall survival in a post-hoc analysis, Andrew Berens of SVB Securities pointed out at the time.
Seagen initiated a Phase III trial in February dubbed MOUNTAINEER-03, which is intended to serve as a confirmatory trial in the US. That study will assess Tukysa with or without cetuximab or bevacizumab in first-line patients.