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Pirtobrutinib fda breakthrough therapy designation date?

See the DrugPatentWatch profile for Pirtobrutinib

What date did the FDA grant pirtobrutinib Breakthrough Therapy designation?

The FDA granted Breakthrough Therapy designation to pirtobrutinib on January 31, 2019 [1].

What is pirtobrutinib, and Breakthrough Therapy designation for what use?

Pirtobrutinib (Jaypirca) is a treatment for certain patients with relapsed or refractory mantle cell lymphoma and is also being studied/approved across other B-cell malignancies where it may address unmet need. The Breakthrough Therapy designation is tied to the FDA’s view of potential to show substantial improvement over existing therapies in the relevant setting [1].

Source

[1] https://www.drugpatentwatch.com/pirtobrutinib-fda-breakthrough-therapy-designation/



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