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Drug approvals and pharmaceutical affairs in Japan
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11/03/05
Anticancer PR
Filed under: Anticancers
Posted by: Kanri @ 4:41 pm

In a rare PR move, the MHLW made publicly available through the mass media the previously adopted decision regarding changes in the approval qualification for anticancer drugs. Today Kyodo News Agency distributed in bilingual format the announcement that from April 1, 2006 the NDAs for anticancer drugs should include - along with the efficacy and safety profiles, data proving prolongation of patient life. Yet another of the Iressa aftershocks…

The new guideline from MHLW stipulates that data from Phase III studies in patients with non-small cell lung, stomach, large intestine and breast cancer should contain detailed evidences for life prolongation.

Ironically, Iressa (gefitinib) was one of the very few New Chemical Entities (NCE) to be first internationally approved in Japan and it turned into a regulator’s nightmare, as the cases of fatal interstitial pneumonia reached to the tabloids. Ever since the first news about lethal side effects of Iressa appeared in 2002, the MHLW found itself between rock and hard place: criticized for both negligence in "hastily" approving Iressa and systematically failing to approve other advanced anticancers.

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