Rozlytrek

Oncology· 499 cited findings· 1 source document

Company: Roche Holding AG

What the regulatory reviews say

Rozlytrek (entrectinib) is indicated for the treatment of NTRK fusion-positive solid tumors and ROS1 fusion-positive non-small cell lung cancer. In pediatric patients with NTRK+ primary CNS tumors, the objective response rate (ORR) point estimate for entrectinib was 60%, compared to 38% for larotrectinib. The overall Objective Response Rate (ORR) was 72.7%, with a Complete Response (CR) of 45.5% and a Partial Response (PR) of 27.3%. The median time to confirmed objective response was 1.86 months. For pediatric patients with NTRK fusion, the responder rate was 64%, and for ROS1 fusion-positive pediatric patients, it was 63%.

Safety findings in pediatric patients include 55 (75%) experiencing treatment-emergent adverse events of grade 3 or higher, and 34 (47%) experiencing serious adverse events. A total of 18 (25%) pediatric patients experienced at least one mild to severe bone fracture, with a median time to first bone fracture of 190 days. The p-value for age as a predictor of bone fractures was 0.005. Treatment discontinuation occurred in 47.7% of patients, with 23.8% discontinuing due to an adverse event.

Rozlytrek received conditional marketing authorization in the EU on 31 July 2020. The International Birth Date (IBD) for Rozlytrek is 18 June 2019. The due date for a pooled analysis of NTRK fusion-positive patients, interim safety and efficacy analysis, and results from tumor genomic profiling is 31 March 2027.

Key figures — cited to the source page

ORR point estimate in pediatric NTRK+ primary CNS tumours (entrectinib)	60	Roche Holding AG — Rozlytrek EMA EPAR variation assessment r, p.135
ORR point estimate in pediatric NTRK+ primary CNS tumours (larotrectinib)	38	Roche Holding AG — Rozlytrek EMA EPAR variation assessment r, p.135
Objective Response Rate (ORR)	72.7%	Roche Holding AG — Rozlytrek EMA EPAR variation assessment r, p.78
Responder rate in NTRK fusion-positive pediatric patients	64	Roche Holding AG — Rozlytrek EMA EPAR variation assessment r, p.44
Pediatric patients with treatment-emergent AE grade 3 or higher	55 (75%)	Roche Holding AG — Rozlytrek EMA EPAR variation assessment r, p.48
Pediatric patients with at least one mild to severe bone fracture (Grade 1 to 3)	18 (25%)	Roche Holding AG — Rozlytrek EMA EPAR variation assessment r, p.51
Conditional marketing authorisation date for Rozlytrek in EU	31 July 2020	Roche Holding AG — Rozlytrek EMA EPAR variation assessment r, p.118
Date of CHMP positive opinion	25 April 2024	Roche Holding AG — Rozlytrek EMA EPAR variation assessment r, p.9

Source documents

Roche Holding AG — Rozlytrek EMA EPAR variation assessment report (EMEA/H/C/004936, 2020) (2020)

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Figures are as stated in the cited regulatory review documents (different drugs are studied in different trials — values are not head-to-head comparisons). Educational reference only — not medical or investment advice.