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FDA Accepts NDA for Bosutinib

Hi Everyone,

This was posted by Jerry Mayfield on his site this morning.

FDA Accepts NDA for Bosutinib

Pfizer Announces FDA Acceptance Of New Drug Application For Bosutinib For Patients With Previously Treated Ph+ Chronic Myeloid Leukemia

January 27, 2012 08:00 AM Eastern Time

NEW YORK--(BUSINESS WIRE)--Pfizer Inc. announced today that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for standard review of bosutinib as a treatment option for adult patients with previously treated Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML). This submission was based on efficacy and safety data from Study 200, a single-arm study of bosutinib in over 500 patients with previously treated Ph+ CML, including patients resistant or intolerant to imatinib as well as patients who were previously treated with dasatinib or nilotinib. Currently, there are no approved therapies available for CML patients after second-line treatment with dasatinib or nilotinib.

Cheers,

Don

Hi Don,

thanks for this update on bosutinib.  In the UK bosutinib has entered the NICE HTA process and is the process of being appraised for cost effectiveness as a 1st line therapy (Pfizer are not applying for 2nd line).

The NICE process for this TKi started with the scoping meeting in September last year.

We are looking at late summer for the Appraisal Committee Decision with a final recommendation in June 2013.

Meanwhile we are in Manchester for the NICE committe meeting tomorrow (Wed) that will decide if dasatinib and nilotinib will be available for 1st line use in UK. 

Hope you are well - thanks again,

Best as always,

Sandy