New standard of care? FDA hands Pfizer, Merck KGaA an OK for Bavencio in bladder cancer
The breakthrough therapy designation Pfizer and Merck KGaA notched for Bavencio in bladder cancer has quickly paved way for a full approval.
The PD-L1 drug is now sanctioned as a first-line maintenance treatment for patients with locally advanced or metastatic urothelial carcinoma, applicable in cases where cancer hasn’t progressed after platinum-containing chemotherapy.
Petros Grivas, the principal investigator of the supporting Phase III JAVELIN Bladder 100, called the approval “one of the most significant advances in the treatment paradigm in this setting in 30 years.”
In the study, patients on Bavencio lived, on average, 7.1 months longer than those given best supportive care, representing a 31% reduction in the risk of death.
“With median overall survival of more than 21 months measured from randomization, the longest overall survival in a Phase III trial in advanced urothelial carcinoma, the JAVELIN Bladder 100 regimen with avelumab as a first-line switch maintenance treatment has the potential to become a new standard of care based on its proven ability to reinforce the benefit (response or stable disease) of induction chemotherapy and extend the lives of patients with this devastating disease,” Grivas said in a statement.
Although chemotherapy tends to induce high response rates, most patients ultimately experience disease progression within nine months, the companies noted. Among those whose cancer has already metastasized at diagnosis, only 5% would live longer than five years.
It’s now up to the commercial and medical affairs teams at Pfizer and Merck KGaA to realize that fundamental shift in standard of care they envision.
The drug was already sanctioned, under accelerated approval, for use in patients following disease progression — based on tumor response and duration of response back in 2017.
The new OK — one of the few bright spots in Bavencio’s checkered development history — also highlights the sort of speed developers can expect under the FDA’s real-time oncology review (RTOR) pilot program. The partners completed their sBLA submission in early April, although the three-month review is still relatively long compared to what Merck saw with Keytruda in a certain subtype of colorectal cancer.