Blue­print Med­i­cines po­ten­tial­ly de­lays Ay­vak­it de­ci­sion; Con­trol beats treat­ment in mesothe­lioma tri­al

→ Blue­print Med­i­cines filed an amend­ment to its ap­pli­ca­tion to get the gas­troin­testi­nal stro­mal tu­mor (GIST) drug Ay­vak­it ap­proved in fourth-line GIST, the com­pa­ny dis­closed in the prospec­tus for a new $325 mil­lion pub­lic of­fer­ing.  Blue­print got a big ac­cel­er­at­ed OK on the drug this month in a par­tic­u­lar mu­ta­tion, but be­cause the FDA de­cid­ed to split their re­view in two, they didn’t hear on fourth-line GIST. They were sup­posed to hear be­fore Feb­ru­ary 14, but this amend­ment could push that date back by 3 months. Blue­print wrote that the amend­ment is de­signed to al­low the com­pa­ny to com­ply with the FDA’s re­quest for da­ta from the Phase III VOY­AGER be­fore they give a judg­ment.

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