A targeted drug from Seagen and Astellas Pharma can now be prescribed more widely in bladder cancer, after the Food and Drug Administration granted a conditional approval for its use in certain people whose disease hasn’t yet been treated.
The regulator cleared the companies’ drug Padcev together with Merck & Co.’s immunotherapy Keytruda as a combination regimen for first-line treatment of locally advanced or metastatic urothelial cancer, Seagen said late Monday. The OK is only for patients who are ineligible to receive a type of chemotherapy called cisplatin.
Seagen and Astellas’ approval application was supported by results from a mid-stage trial that showed the two drugs together shrank tumors in nearly two-thirds of study participants. They are running a larger study that’s designed to confirm the regimen’s benefit in delaying cancer progression and extending patient survival. Initial data are expected later this year.
The approval is viewed as important to unlocking a wider market opportunity for Padcev, a type of therapy known as an antibody-drug conjugate. Developed by Seagen and Astellas, the therapy won an initial U.S. approval in late 2019 for later-stage use in bladder cancer.
“The accelerated approval for the combination of Padcev and [Keytruda] marks an important milestone for the approximately 8,000 to 9,000 patients in the United States with locally advanced or metastatic urothelial cancer who are not eligible for cisplatin-containing chemotherapy,” said Ahsan Arozullah, head of oncology development at Astellas, in the companies’ statement.
Its clearance for first-line treatment comes a few weeks after Pfizer agreed to buy Seagen for $43 billion. The deal would give Pfizer ownership of the biotech’s portfolio of cancer drugs, which includes three other approved medicines besides Padcev.
“We take the approval as a clear win for ADC drug development and helps validate the timing of the Pfizer merger agreement,” wrote Dane Leone, an analyst with Raymond James, in a note to clients.
Leone estimates the market opportunity for first-line bladder cancer in cisplatin-ineligible patients to be greater than $1 billion in peak annual sales.
Padcev’s labeling includes a safety warning for serious skin reactions, as well as cautions of other side effects like nerve damage, high blood sugar, a type of lung disease and eye disorders.
Shares in Seagen rose by about 1% in Tuesday morning trading.