Please login to the form below

Not currently logged in
Email:
Password:

Pfizer gets US approval for leukaemia drug Bosulif

FDA grants the tyrosine kinase inhibitor a licence to treat chronic myelogenous leukaemia

Pfizer has been granted approval by the FDA for tyrosine kinase inhibitor Bosulif as an orphan drug to treat a form of chronic myelogenous leukaemia (CML) which affects around 5,500 patients in the US a year.

Bosulif (bosutinib) is indicated for patients with chronic, accelerated or blast phase Philadelphia chromosome-positive CML who are resistant to, or who cannot tolerate, other therapies, including Novartis' Glivec/Gleevec (imatinib).

The treatment of CML was transformed by the arrival of Glivec onto the market in 2001 but, while survival improved, the development of resistance to therapy and disease progression has meant there is a need for additional lines of drug therapy.

"Despite recent advances, an unmet need remains for many CML patients who are refractory to one or more tyrosine kinase inhibitors," said Dr Jorge Cortes of MD Anderson Cancer Centre in Texas, a lead investigator in the clinical trial programme for Bosulif.

Pfizer's drug joins two other tyrosine kinase inhibitors used in the second-line treatment setting, namely Bristol-Myers Squibb/Otsuka's Sprycel (dasatinib) and Novartis' Tasigna (nilotinib)

Its approval was based on the results of a single clinical trial in 546 patients treated earlier with Glivec in which 34 per cent of patients achieved a major cytogenetic response with bosutinib after 24 weeks, compared to 27 per cent of those treated with Sprycel or Tasigna.

Of the patients who achieved a major cytogenetic response at any time, 52.8 per cent had their response last at least 18 months, according to the FDA.

In patients with accelerated CML previously treated with at least Glivec, 33 per cent had their blood counts return to normal range, known as a complete haematologic response. 

All told, 55 per cent of patients achieved normal blood counts with no evidence of leukaemia - an overall haematologic response - within the first 48 weeks of treatment. And 15 per cent and 28 per cent of patients with blast phase CML achieved complete hematologic response and overall hematologic response, respectively.

Meanwhile, various other drug candidates are coming through the pipeline for CML, including Ariad's much-fancied tyrosine kinase inhibitor ponatinib - which was filed for approval in the US in June and in Europe last week and tackles a genetic mutation in CML (T3151) that is not addressed by other therapies.

Other competition in the coming years could emerge from the likes of Cephalon/Hospira's Omapro (omacetaxine), BioSante Pharma's GVAX and Deciphera's ABL inhibitor rebastinib (DCC-2036).

5th September 2012

From: Sales

Share

Tags

Related Hub content

Featured jobs

Subscribe to our email news alerts

PMHub

Add my company
Wisepress

Wisepress is a medical bookseller promoting and selling books worldwide, both online and via the 200 European medical conferences that...

Latest intelligence

BrAInPME.png
The future of medical content: The personal touch
The purpose of delivering personalised content to HCPs is not just about customer experience, it's about improving healthcare. Our Commercial Director, Tib Catania discusses what ‘deep learning’ means for the...
Rise of the patient expert - an interview with Michael Seres
Founded by Michael Seres in 2011, 11 Health is a connected medical device company currently working to change the lives of patients using stoma bags. Content Marketing Manager Liz Inskip...
Making sense of Nutraceuticals in China
Published in eyeforpharma February 2017 by Marc Yates...

Infographics