Tissue-agnostic NDA one of two planned Ignyta submissions

Ignyta Inc. (NASDAQ: RXDX) said Thursday it hopes to submit two NDAs to FDA in 2018 for entrectinib (RXDX-101), including a tissue-agnostic indication for tyrosine kinase receptor (TRK) fusion-positive cancers. The company intends to submit a separate NDA for c-ros proto-oncogene 1 receptor tyrosine kinase (ROS1)-positive non-small cell lung cancer (NSCLC).

Interim data reported Thursday from the pivotal Phase II STARTRK-2 basket study showed that in 32 evaluable patients with ROS1 fusion-positive NSCLC, entrectinib led to an objective response rate (ORR) of 75%. Entrectinib also led to a median duration of response of 17.2 months among responders, and progression-free survival (PFS) of 19.1 months among all patients. In 11 ROS1 NSCLC patients with CNS metastases, the ORR was 64%...