Seattle Genetics has racked up its second Food and Drug Administration approval, for a drug to treat a form of bladder cancer.
The Bothell, Washington-based biotech company and Japanese drugmaker Astellas said Wednesday that the FDA had granted accelerated approval to Padcev (enfortumab vedotin-ejfv) for locally advanced or metastatic urothelial carcinoma, the most common form of bladder cancer. The companies said the drug is the first to win approval for patients who have already had a combination of platinum chemotherapy and a PD-1 or PD-L1 checkpoint inhibitor.
Shares of Seattle Genetics rose 5.5% on the Nasdaq when markets opened Thursday. Shares of Astellas were mostly flat on the news.
Padcev marks Seattle Genetics’ second regulatory approval since Adcetris (brentuximab vedotin), which won approval in 2011 for Hodgkin’s lymphoma and systemic anaplastic large-cell lymphoma, a form of T-cell non-Hodgkin’s lymphoma. Since then, it has racked up additional approvals as well.
Like Adcetris, Padcev is an antibody-drug conjugate, consisting of a monoclonal antibody – in this case one that targets a cell-surface antigen commonly expressed in bladder cancer called Nectin-4 – with an attached pharmaceutical payload.
“Metastatic urothelial cancer is an aggressive and devastating disease with limited treatment options, and the approval of Padcev is a significant advance for these patients who previously had limited options after initial therapies failed,” said Dr. Jonathan Rosenberg, chief of Memorial Sloan Kettering Cancer Center’s genitourinary medical oncology service, in a statement. “The Padcev clinical trial enrolled a range of patients whose cancer was difficult to treat, including those whose disease had spread to the liver.”
Also on Wednesday, the FDA granted a Breakthrough Therapy designation to its investigational drug tucatinib, which it is developing as a treatment for HER2-positive breast cancer, in combination with the chemotherapy drug capecitabine and Roche’s Herceptin (trastuzumab). Results from the pivotal clinical trial of the drug presented Dec. 11 at the San Antonio Breast Cancer Symposium showed that among 480 patients, the three-drug combination outperformed Herceptin and capecitabine alone on the primary endpoint of progression-free survival, with a statistically significant 46% reduction in the risk of progression.
The latest news has Seattle Genetics faring better than it has in the past in its efforts to develop drugs to add to its portfolio. In June 2017, it discontinued the Phase III CASCADE study of SGN-CD33A (vadastuximab talirine) in frontline acute myeloid leukemia after an independent data monitoring committee review revealed a higher rate of deaths, including fatal infections, among patients receiving the drug than among those in the control arm.
Photo: Waldemarus, Getty Images
