OncologySTAT.com featured this Pink Sheet Daily article a few weeks ago. The fact there are several good, front-line chemo drugs for use against chronic myeloid leukemia is good news, but not the story here. This is a business story–a battle between drugs and drug companies. Read the first part of the article and see what you think:
Bristol’s Once-daily Sprycel Faces Off Against Novartis’ Tasigna After Clearance in First-line Leukemia
The Pink Sheet Daily. 2010 Oct 28, E Hayes
Following accelerated approval of a supplemental application, Bristol-Myers Squibb’s Sprycel in first-line chronic myeloid leukemia, the commercial race against Novartis’ Tasigna is about to begin.
Bristol and Novarits have aspired to dominate first-line CML with their BCR-ABL kinase inhibitors and replace the market leading Gleevec (imatinib), also from Novartis, which is due to go off-patent in 2015. In trials presented at the American Society of Clinical Oncology meeting in June, both candidates both proved to have superior efficacy to Gleevec.
Sprycel was cleared by FDA in front-line treatment of Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase, a rare blood cancer, on Oct. 28, following approval in Europe on Oct. 26. It already had a second-line approval from FDA for treatment of Philadelphia chromosome positive CML in patients resistant to or intolerant to imatinib.
Bristol is betting that among other things, the product will stand out as being the first-line treatment with a once-daily dosing schedule and no fasting requirements.
Also cleared through accelerated approval, Novartis’ twice-daily Tasigna (nilotinib) was approved by FDA for first-line CML in July, supplementing a second-line approval. Tasigna was also recently approved in Europe for first-line use. Novartis is positioning the drug as the successor to the wildly successful Gleevec, which may be given at 400 and 600 mg doses once-a-day, according to the label, but needs to be taken twice daily at doses of 800 mg and up.
Approval of Sprycel came with a ringing endorsement from FDA. In a press statement, Office of Oncology Drug Products Director Richard Pazdur noted the importance of accelerated approval in providing drugs that serve an unmet need, and that new drugs have “dramatically changed the lives of patients” with CML.
Read more about this interesting battle between cancer therapies by going to:
The commercial race against Novartis’ Tasigna is about to begin.
Feel good and keep smiling! Pat