AstraZeneca’s Imfinzi won its bladder cancer approval just last week—but it’s no longer the newest immuno-oncology med for the condition.
Pfizer and Merck KGaA’s Bavencio (avelumab) nabbed its own accelerated FDA OK on Tuesday, with the advanced or metastatic urothelial carcinoma nod marking its second indication overall. The pair has set the wholesale acquisition cost for the med at $13,000 per month, based on the average patient, a Merck KGaA spokesman said.
At that price, Bavencio will come in just a tad more expensive than Tecentriq from Roche—which last May became the first checkpoint inhibitor to enter the bladder cancer space—and Bristol-Myers Squibb’s Opdivo, both of which bear $12,500 stickers. And the newcomer will match Imfinzi, which AZ pegged at $13,000.
The new approval comes based on a 242-patient study that showed an overall response rate of 13.3% among patients who had been followed for at least 13 weeks and 16.1% among those followed for at least six months.
“We are delighted to have taken another step forward with our immunotherapy today with this second approval, together with our partner Pfizer. It is fulfilling to see our drive and commitment continue to help patients with challenging cancers,” Luciano Rossetti, M.D., the R&D head of Merck KGaA’s biopharma business, said in a statement.
The approval, which follows not long after Bavencio’s late March go-ahead in rare skin cancer Merkel cell carcinoma, comes amid questions from industry watchers about whether Pfizer will stick with its Merck KGaA partnership. Analysts have questioned whether the deal-hungry buyer would jump ship if, say, Bristol-Myers—whose recent immuno-oncology woes have sunk its stock price—became available.
Pfizer, though, recently insisted that it’s not planning to pull the trigger on a large deal—something it has the ability to do, CEO Ian Read said—anytime soon. That may be because it’s waiting to see whether the CTLA-4 lung-cancer combo approach both Bristol-Myers and AstraZeneca are trialing can prevail over chemo combos, which New Jersey's Merck and Roche are pursuing. Merck's Keytruda is up for a chemo-combo use in lung cancer, with an FDA decision on that new indication due Wednesday.
But Read has also said Pfizer is “committed” to its German counterpart and remains “focused on developing avelumab.”
Meanwhile, Bavencio may not be the new kid on the bladder-cancer block for long. Keytruda, which already boasts indications in lung cancer, melanoma, head and neck cancer and more, is also vying for a nod in the space.