Turn­ing Point touts pos­i­tive piv­otal NSCLC da­ta, hints at even faster OK — but can it beat Pfiz­er and Roche?

Turn­ing Point Ther­a­peu­tics has long set a clear goal to shoot for an ac­cel­er­at­ed ap­proval of re­potrec­tinib, its ty­ro­sine ki­nase in­hibitor for ROS1- or NTRK-dri­ven tu­mors. Now armed with pos­i­tive, if pre­lim­i­nary, Phase II da­ta, the biotech said they may be FDA-ready even soon­er than ex­pect­ed.

On view this morn­ing is a slate of over­all re­sponse rates from 39 pa­tients across five dif­fer­ent co­horts in the reg­is­tra­tional por­tion of the TRI­DENT-1 study. All have non-small cell lung can­cer, and four of the groups have tu­mors bear­ing ROS-1 fu­sions while the last is a NTRK+ arm.

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