March 24 (Reuters) - The European Union's medicines
regulator said on Tuesday it expects Baxter International's ( BAX )
cancer drugs containing ifosfamide will remain in
shortage in the bloc well into the first quarter of next year.
Ifosfamide is used by itself or in combination with other
therapies to treat multiple cancers including testicular, small
cell and cervical cancers.
The European Medicines Agency said the shortage was due to a
technical disruption at Baxter's contract manufacturing site,
but did not disclose details.
* Baxter is the primary supplier of ifosfamide across the
EU.
* The brands, Holoxan, Tronoxal and Mitoxana, contain
ifosfamide either as the main ingredient or as a combination
with other drugs.
* Manufacturing and release of ifosfamide-containing
products had halted in September, but their production has now
resumed, albeit at a constrained level.
* The reduced capacity at the site is resulting in
limited supply of ifosfamide which will gradually improve
through 2026, Baxter said in an emailed response to Reuters.
* "We are working with urgency alongside our
manufacturing partner and in coordination with the European
Medicines Agency and other relevant stakeholders to restore
supply as quickly and responsibly as possible, Baxter added.
* The regulator last month had also warned of a shortage of
another cancer drug by Baxter, cyclophosphamide - a key
ingredient in Endoxan, Sendoxan and Genoxal - until the first
quarter of next year due to a site disruption.
* The shortages come at a time when the Middle East war is
already threatening to disrupt the flow of medicines amid
restricted air transit and closed shipping routes.