Novartis speeds up Tasigna programme
pharmafile | July 25, 2006 | News story | Sales and Marketing |Â Â Â
Novartis' new cancer drug will be submitted earlier than expected for European and US approval after showing positive results in clinical trials.
Tasigna is a new drug for Philadelphia chromosome-positive chronic myeloid leukaemia (Ph+ CML) which can treat patients who are unable to use Novartis' blockbuster Glivec.
In clinical trials, 92% of Ph+ CML patients who showed resistance or intolerance to Glivec achieved normal white blood cell counts when taking Tasigna.
Following the trial results, Novartis will now submit Tasigna (nilotinib) with US and European regulators in late 2006, rather than 2007 as previously planned. Tasigna has orphan drug status in both the US and Europe and the FDA has fast-tracked its US approval process.
Tasigna's main competitor will be Bristol-Myers Squibb's Sprycel (dasatinib). This drug was approved in the US at the end of June for Ph+ acute lyymphoblastic leukaemia and CML in patients with resistance or intolerance to prior therapy, including Glivec, which is a key drug in Novartis portfolio, generating sales of $1.2 billion in the first half of 2006. Sprycel was filed with European regulators for the same two indications in January this year and has received positive opinions for both from the EMEA's advisory committee as an orphan drug.
Sprycel, Tasigna and Glivec all work by inhibiting the cancer-causing Bcr-Abl gene, but in CML patients, Glivec is associated with mutations in the gene, which then interfere with the drug's mechanism of action, resulting in resistance.
Despite this, Glivec is currently the gold standard for CML as it has numerous advantages; however, weaknesses have begun to emerge in its five years on the market, as it has been estimated that approximately 4% of newly diagnosed CML patients have already developed Glivec resistance, while up to 20% develop resistance over time.
In clinical trials, both Tasigna and Sprycel have demonstrated the ability to overcome Glivec resistance representing a significant development in the treatment of patients.
With Sprycel the first to market in the US and likely to be launched in Europe before its rival, BMS will be looking to make the most of this advantage while Tasigna awaits approval. However, Novartis' extensive experience in the CML market is sure to prove invaluable once Tasigna is approved.
