Neil Desai, Aadi Bioscience CEO (via YouTube)

FDA ap­proves pricey new treat­ment for ul­tra-rare and ag­gres­sive form of sar­co­ma

The FDA on Tues­day ap­proved Aa­di Bio­science’s first drug and the first treat­ment ap­proved specif­i­cal­ly for pa­tients with an ul­tra-rare and ag­gres­sive form of sar­co­ma that oc­curs most­ly in women.

The ap­proval of the drug, known as Fyarro, is for those with lo­cal­ly ad­vanced un­re­sectable or metasta­t­ic ma­lig­nant perivas­cu­lar ep­ithe­lioid cell tu­mor (PECo­ma), and is based on a Phase II tri­al.

Re­sults showed an over­all re­sponse rate as as­sessed by in­de­pen­dent re­view of 39% (12/31), with two pa­tients achiev­ing a com­plete re­sponse af­ter pro­longed fol­low up, Aa­di said. The com­pa­ny al­so said that among re­spon­ders, 92% had a re­sponse last­ing greater than or equal to six months; 67% had a re­sponse last­ing greater than or equal to 12 months; and 58% had a re­sponse last­ing greater than or equal to two years.

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