Tasigna more effective than Glivec, says Novartis
pharmafile | June 21, 2010 | News story | Research and Development, Sales and Marketing | Glivec, Novartis, Tasigna, leukaemia
Novartis has gained US approval for Tasigna to be used as a front line treatment for chronic myeloid leukaemia.
The FDA approval was based on a new head-to-head trial between Tasigna (nilotinib) and Novartis’s other CML treatment, Glivec (imatinib).
Glivec has been a landmark success not only for Novartis, but for the pharma industry as a whole, being one of the first and most clinically effective ‘targeted therapies’ for cancer. The drug is so effective in extending lives that most patients with Philadelphia chromosome-positive (Ph+) CML achieve a five-year survival, a feat rarely seen in cancer patients.
Glivec is the company’s second biggest earner (behind blood pressure treatment Diovan) earning $3.94 billion in 2009.
Glivec has until 2015 before its patent expires, but Novartis is nevertheless keen for Tasigna to succeed it as the treatment of choice. One reasons for this is that despite the effectiveness of Glivec, many patients start to develop resistance to the drug, while Tasigna remains effective.
Novartis is also looking to fend off competition from another drug in the therapy area, Bristol Myers Squibb’s Sprycel (dasatinib), which recently produced data showing its response rate was superior to Glivec.
Commenting on the new approval and phase III head-to-head data, Hervé Hoppenot, president of Novartis Oncology said: “With the faster and deeper responses we are seeing with Tasigna, newly diagnosed CML patients will have a new and more effective treatment option.”
Tasigna is a potent and selective inhibitor of the Bcr-Abl protein that causes production of cancer cells in Ph+ CML. It is also active against a broad spectrum of Bcr-Abl mutations associated with resistance to Glivec. First approved in 2007, until now Tasigna has only been licenced as a second line treatment.
The pivotal head-to-head trial showed Tasigna surpassed Glivec in key measures of treatment efficacy, as has been previously reported. Tasigna eliminated Bcr-Abl faster than Glivec, resulting in lower rates of cancer progression even as early as 12 months.
Deep reduction of Bcr-Abl, known as a ‘major molecular response’, is considered to be a critical therapeutic milestone linked to good long-term outcomes for patients with Ph+ CML. Tasigna produced higher rates of both major molecular response and complete cytogenetic response (elimination of the Philadelphia chromosome that is the hallmark of the cancer) compared with Glivec.
Andrew McConaghie
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