Bosulif

At a Glance
Therapeutic Area:
Chronic myeloid leukemia (CML)
Approved Applications:
BOSULIF® is an oral, once-daily, TKI which inhibits the Bcr-Abl kinase that promotes CML; it is also an inhibitor of Src-family kinases. BOSULIF is currently approved in the U.S. for the treatment of adult patients with Ph+ CML with resistance or intolerance to prior therapy and offers an important treatment option for these patients. In Europe, BOSULIF was granted conditional marketing authorization for the treatment of adult patients with Ph+ CML previously treated with one or more TKIs and for whom imatinib, nilotinib and dasatinib are not considered appropriate treatment options.
Applications In Development:
Patients with newly diagnosed chronic phase Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML).
Acquisition Date:
May 2014
Royalty Seller:
Pfizer is the payor of the economics triggered by approval.
Partner:
Marketer:

Bosulif
"This successful partnership between Pfizer and Avillion is good news for CML patients because additional first-line treatment options allow physicians to tailor therapy based on individual patient considerations. Since its approval, the efficacy and distinct tolerability profile of BOSULIF has provided an important treatment option for patients with Ph+ CML who are resistant or intolerant to prior therapy. The positive outcome of the BFORE study represents a key step in potentially broadening treatment options for patients in the first-line setting,” said Mace Rothenberg, MD, chief development officer, Oncology, Pfizer Global Product Development. “This is an important milestone for Pfizer’s emerging hematology portfolio as we work to develop new treatments for patients with acute and chronic hematologic malignancies.”

 

Latest News

  • U.S. FDA and European Medicines Agency Accept Regulatory Submissions for BOSULIF® (bosutinib) for the Treatment of Patients with Newly Diagnosed Ph+ Chronic Myeloid Leukemia
    29 August 2017
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