Loxo Oncology Inc (NASDAQ:LOXO) is targeting to file for regulatory approval of its gene mutation cancer drug candidate larotrectinib at the end of next year or early in 2018. But is that mission possible?
A closer look at Loxo’s update on larotrectinib suggests the target is within reach. For instance, the company said that enrollment of patients for a Phase 2 study of larotrectinib (LOXO-101) is underway and is on track to be completed in early 2017.
If the enrollment is completed on time as expected, Loxo expects to report results of the Phase 2 study in the back half of 2017. That should allow the company to file for regulatory clearance in at the end of 2017 or early 2018.
Aiming for 2018 approval
Because of the positive outcomes that have already been seen from the trials of larotrectinib, especially in an early Phase 1 study, Loxo is hopeful theh Phase 2 study will meet expectations and pave the way for accelerated approval of the drug. Loxo is aiming to have the drug approved in 2018.
Loxo’s larotrectinib was developed as a precision cancer drug. As such, it aims at specific genetic mutations rather than anatomical location of a tumor. Loxo is studying larotrectinib in patients with a genetic mutation called TRK gene fusion. The FDA has already granted the candidate a crucial clearance that should allow for accelerated marketing approval.
Patients who have received larotrectinib treatment are monitored for tumor shrinkage and response duration.
Impressive Phase 1 study outcome
The results from the Phase 1 study of larotrectinib that Loxo presented at a cancer meeting showed that the majority of patients who received the treatment responded well. Of the eight patients enrolled in the Phase 1 study, six showed no progression in their tumor after 11 to 22 months of treatment. These positive results give Loxo confidence as it prepares for the next stage of testing larotrectinib.
“Based on current enrollment and written regulatory correspondence, we are able to provide this exciting update for larotrectinib, and begin planning for a potential commercial launch,” said Loxo’s CEO Josh Bilenker.
Loxo stock jumped nearly 26% to close at $33.86 in the last session. The stock is up more than 19% since the beginning of 2016.
