Novartis questions AstraZeneca cancer data
pharmafile | October 21, 2003 | News story | |
Novartis has questioned the evidence behind a UK licence extension to AstraZeneca breast cancer drug Arimidex.
The Medicines Control Agency licence follows a similar US approval, and will allow Arimidex to challenge tamoxifen as the treatment of choice following surgery or radiotherapy treatment of the disease.
The drug will provide a new choice for oestrogen receptor-positive post-menopausal women who are unable to take tamoxifen because of high risk of blood clots or endometrial abnormalities.
The new licence has attracted the ire of Novartis because Arimidex trial data has yet to produce evidence that the drug improves patientschances of survival.
AstraZeneca phase III ATAC study showed the drug was superior to tamoxifen for the primary end point, time to disease recurrence, but the immaturity of the data means Arimidex long-term benefits in these cases are still unclear.
Novartis has now issued a press release underlining this fact to UK physicians while promoting the potential of its rival product, Femara.
The company acknowledged that Arimidex new licence would ead to a significant increase in treatment optionsbut added: lthough the ATAC data is positive in this preliminary analysis the data need to mature before breast cancer specialists can be clear about the actual benefits of the aromatase inhibitor anastrozole over tamoxifen.
Another member of the aromatase inhibitor class, Femara is currently in large-scale trials designed to address a number of treatment issues, with key data on survival rates expected in 2004.
Arimidex has been granted the same licence in the US as part of an accelerated approval on the understanding that AstraZeneca will complete its trials and submit mature survival and safety data to verify the product safety and effectiveness.
There are currently no plans for NICE to review the aromatase inhibitor class, with the only on-going appraisal in the breast cancer field being that of Roche Xeloda, due in early 2003.
