Tasigna Beats Sprycel to First-Line CML Punch

 J Merrill

Now that Novartis' Tasigna (nilotinib) has been approved by FDA for the treatment of first-line chronic myeloid leukemia, the race has officially begun for two second-generation BCR-ABL kinase inhibitors to supplant the venerable market-leader, Novartis' Gleevec (imatinib).

The other competitor expected soon to be vying for a piece of the first-line market is Bristol-Myers Squibb with its Sprycel (dasatinib). That drug, approved since 2006 for second-line CML, has not yet been cleared for first line but did demonstrate superiority over Gleevec in a Phase III clinical trial. Bristol has recently filed an sNDA seeking FDA approval for the indication.

Toppling Gleevec - a highly efficacious and safe drug that has transformed CML into a chronic disease for many patients - won't be easy. The biggest challenge will come when Gleevec goes generic (likely in 2015), opening the door to low-cost versions. Already, interested parties are looking to these drugs as a harbinger for market forces in other therapeutic areas.

As its patent life erodes, Gleevec will be one of the first examples of a high-priced, highly effective targeted oncology drug to go generic. Availability of a generic will raise questions about how much payers and patients are willing to pay for second-generation drugs that cost tens of thousands of dollars a year while offering only modest benefits over the cheaper original. Such situations have happened in other therapeutic areas, but not in cancer nor for such a high-priced treatment.

Long-Term Survival Data Will Be Key

Whether payers will be able to make a case for using generic Gleevec first before trying the newer drugs will likely come down to long-term data, collected over the next five years, to demonstrate that Tasigna and Sprycel have a survival advantage over Gleevec.

Gleevec is a small molecule drug, not a biologic, and thus development or manufacturing hurdles aren't likely to deter multiple competitors' generics from reaching the market. 

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