- The FDA and European Medicines Agency have accepted for review Pfizer 's (NYSE:PFE) marketing applications seeking approval to use BOSULIF (bosutinib) to treat patients with newly diagnosed chronic phase Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML).
- The indication has Priority Review status in the U.S. which shortens the review clock to six months, although Pfizer says the FDA's action date (PDUFA) is in December. It is currently approved in the U.S. for adult patients with Ph+ CML who have not responded to prior therapy. In Europe, it is approved for Ph+ CML patients who have received prior treatment with one or more tyrosine kinase inhibitors and for whom imatinib, nilotinib and dasatinib are considered inappropriate treatment options.
- Privately held Avillion LLP conducted the study supporting the filing under a 2014 agreement with the company. If approved, it will be eligible to receive milestone payments from Pfizer, the owner of global commercialization rights.
- PFE is down 1% premarket on light volume.
- Now read: Pfizer Looks To Sneak In the Market Before Heavy Hitters
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