After rejection, FDA re-accepts Xspray's application for would-be rival to BMS' Sprycel

With a patent feud settled and its approval application back at the FDA’s desk, Sweden’s Xspray Pharma believes it's on track to launch its first commercial product late this summer.

Following a rejection in 2023, the FDA has accepted the resubmission of Xspray’s application for its leukemia candidate Dasynoc, which is seeking to dethrone Bristol Myers Squibb’s entrenched cancer blockbuster Sprycel (dasatinib). The FDA is now expected to decide on Dasynoc by July 31, Xspray said in a press release Monday.

The candidate is an “improved” version of Bristol's Sprycel, Xspray says, boasting several advantages over its reference product. For one, Dasynoc is unaffected by the pH value of the stomach, which means it can be used together with certain medications, such as omeprazole, to treat peptic ulcers alongside cancer, according to the Swedish company.

Further, Xspray claims Dasynoc allows for more even and consistent uptake of dasatinib in the body and it can be administered at a lower dose than Sprycel, which is expected to yield fewer side effects.

With the new FDA action date in place, Xspray is sticking to its previously announced plan to launch Dasynoc on Sept. 1. Previously, the company had hoped to debut the drug—set to become Xspray’s first commercial product—in the second half of 2023.

Xspray is seeking approval for Dasynoc in chronic myeloid leukemia, where BMS’ Sprycel was approved all the way back in 2010. 

Last July, despite signing off on critical aspects of Xspray’s Dasynoc application, the FDA ultimately slapped the company with a complete response letter. At the time, the agency requested additional information on the drug’s dosing, plus greater clarity around a third-party manufacturing facility. In issuing its rejection, the FDA did not identify any shortfalls pertaining to Dasynoc’s stability or clinical data, Xspray explained last summer.

While the FDA slapdown thwarted Xspray’s plans to launch in 2023, the company achieved a major victory on its Dasynoc campaign in September, when it settled patent litigation with Bristol Myers Squibb. The Sprycel patents involved in the case aren’t due to expire until September 2026, though the resolution allows Xspray to roll out its therapeutic later this year, pending FDA approval.

Despite Sprycel’s age, the drug continues to bring home blockbuster sales for BMS. In 2023, the medicine generated $1.9 billion worldwide. Overseas, a European court decision paved the way for Sprycel generics in 2017.

Xspray, for its part, has tapped commercial services outfit Eversana to help market its first potential product in the U.S. Xspray is set to maintain financial and strategic control over Dasynoc while leveraging Eversana's commercialization team, the partners explained last year.