In the rare disease world, nothing causes rippling waves of excitement quite like a new drug announcement.
So prepare for a tsunami, because that’s exactly what you’re getting… sort of.
Spring 2016, Syros Pharmaceuticals got word that their application for SY-1425—the latest candidate for treating types of relapsed high-risk myelodysplastic syndrome (MDS) and refractory acute myeloid leukemia (AML)—got approved by the FDA.
But there’s one small downside—this drug isn’t anywhere close to being on market. The application that got approved? It was the Investigational New Drug (IND) application, a formal exception that essentially lets Syros transport their drug to trial investigators around the country.
All the approval means is that SY-1425 can now start on Phase 2 of clinical trials for AML and MDS patients.
I don’t want to downplay that accomplishment. Clinical trials are imperative to everyone’s health and safety, so this really isn’t bad news.
The thing is though, that it can be exhausting hearing drug announcement after drug announcement, thinking something is almost at port, only to realize it’s still hanging at the horizon.
Syros, at least, remains confident that SY-1425 is worth the wait:
“[It’s] a promising therapeutic approach for subsets of AML and MDS.”
The company seems excited that this novel option for AML and MDS could roll onto shore any day now. And with the FDA offering different fast-track options for needed therapies, who knows?
Learn more about MDS from the MDS Foundation