Rozlytrek can be prescribed with reimb in Korea

Lands at hospitals and is approved for reimbursement

Passes DCs of SNUH, Severance Hospital, etc.

Will be prescribed in earnest in the field with another tumor-agnostic therapy Vitrakvi

The tumor-agnostic drug Rozlytrek may now be prescribed at general hospitals in Korea.

 

According to industry sources, Roche Korea’s NTRK(Neurotrophic tyrosine receptor kinase) targeted anticancer therapy Rozyltrek (entrectinib) has passed the drug committees of medical institutions including the Seoul National University Hospital, Severance Hospital, and Chungnam National University Hospital.

 

With its competitor, Bayer Korea’s Vitrakvi (Larotrectinib) also being prescribed in SNUH since Q1 this year and both drugs being applied insurance benefit from this month, prescriptions for the drugs are expected to start in earnest in the field.

 

The two drugs may be used in most tumor types with identified NTRK gene fusions.

 

However, reimbursement for the drugs is limited to types of tumors mentioned in the NCCN guidelines.

 

Rozlytrek, which was approved as an orphan drug in April last year may be prescribed for the treatment of adult and pediatric patients 12 years of age and older with solid tumors that have an NTRK gene fusion without a known acquired resistance mutation and for adult patients with locally advanced ROS1-positive or metastatic NSCLC.

 

Rozlytrek was approved based on Phase I/II STARTRK-NG trial on pediatric patients, as well as the pivotal Phase II STARTRK-2 and Phase I STARTRK-1 and ALKA-372-001 trials.

 

In the Phase II STARTRK-2 study, Rozlytrek reduced tumors in more than half (objective response rate [ORR] = 56.9%) of people with NTRK fusion-positive solid tumors.

 

Objective responses to Rozlytrek were seen across 10 different solid tumor types with a median duration of response (DoR) of 10.4 months.

 

Also, the sub-analysis results of Rozlytrek in Asians presented at the ESMO Asia 2020 that was held last year gained much attention.

 

The sub-analysis results in Asians showed that the ORR was 69.2%, the median DoR 10.4 months, and the median progression-free survival (PFS) 14.9 months in 13 patients with NTRK gene fusion-positive solid tumor who received Rozlytrek.

 

However, the overall survival rate was not provided.

 

The median ORR was 69.9% and median DoR 14.9% in ROS1-positive NSCLC patients, with a median OS of 28.3 months and median PFS of 13.6 months.

 

Ahn Myung-Ju, professor of Hemato-Oncology at Samsung Medical Center said, “I hope the introduction of Rozlytrek in Korea and the clinical evidence that confirmed the drug’s potential in Asians will aid the establishment of a virtuous cycle of precision medicine in Korea, a cycle which provides personalized treatment according to the patients’ genetic characteristics for rare cancer patients who had no therapeutic alternatives and their treatment information leading back to research and development.”.