22 TheIinoin gains US approval for acute promyelocytic leukaemia Roche's tretinoin [all-trans retinoic acid; 'Vesanoid'] has been approved by the US FDA for the treatment of acute promyelocytic leukaemia; it is the first retinoid product to gain marketing approval for the treatment of cancer in that country, report the Wall Strut Journal l and the LAnctl. 2 Tretinoin is indicated for the induction of remission in patients with acutc promyelocytic leukaemia who are refractory to, or who have relapsed from, anthracycline-based antineoplastic therapy, or for whom anthracycline-based therapy is cODltaindicated, according to Scrip. 3 Clinica1 tria1s have shown that, when used in combination with other antineoplastic agents. tretinoin results in 'dramatically longer survival' and a 'striking decrease in morbidity and manogeable toxicities', compared with standard therapy alone. claims Roche.

LabellIng limits use However, FDA labelling oftretinoin restricts its use to the first stages of refractory disease. Because of the serious respiratory syndrome associated with use of the drug. the agency warns against long-term maintenance use, reports the Pink. Sheet,· Contrary to labelling, a recent trial sponsored by the US National Cancer Institute showed that first-line andlor maintenance use of tretinoin may lead to more favourable survival rates than standard antineoplastic therapy alone, The benefits of tretinoin may be more profound among patients who receive the agent early in their treatment. adds the Wall Street Journal. I Tretinoin was approved for this indication early this year in Japan. New Zealand, Switzerland, Sweden and the Philippines. 3 Previously, topical tretinoin has been available for the treatment of acne. I I. fDA'~ finI of lit.... CUII:CI" drugl: Roelle II ~ 10 seU viWDi.a A derivative as 1cuke!nilI_ Wall SITed Soumai: B9. 19 Nov 1m 1. McCanby M . FDA~ IJCIinoia far II"ftI!DCGt 01 APt. U:nM:wi: ISS2. 90..: 1m 3. Roche', Yeaanoid~ IDUS.Scrip2(8): II,S 0..: 1m 4. RoeIIe'1 ~ de8n FDAlar rcfrElDry API.. iDditaboa: 00&t analys.i$ rn.n my etlDlc&ls. fresh NO dIU. 1UJ&C'I..tv~ 01 ceU diffc:rml:Wioll.. FOC Rcpona - PIDI< Sbc:a: IS-I6. ~ Oec 1m _ .....

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