The US Food and Drug Administration (FDA) has granted approval to Switzerland-based Roche for its Rozlytrek (entrectinib) intended for the treatment of adults with ROS1-positive and metastatic non-small cell lung cancer (NSCLC), it was reported on Friday.
The firm has also received accelerated approval for the product to treat adult and paediatric patients 12 years of age and older with solid tumours, which have a neurotrophic tyrosine receptor kinase gene fusion without a known acquired resistance mutation.
Rozlytrek is an oral medicine and selective tyrosine kinase inhibitor developed to inhibit the kinase activity of the TRK A/B/C and ROS1 proteins. It holds capacity to inhibit ROS1 and NTRK kinase activity and is likely to result in the death of cancer cells with ROS1 or NTRK gene fusions. The product has received approvals based on data from the integrated analysis of the pivotal phase II STARTRK-2, phase I STARTRK-1 and phase I ALKA-372-001 trials, and data from the phase I/II STARTRK-NG study.
Roche has claimed that Rozlytrek shrank tumours in 78 percent of people with the disease and the duration of response (DoR) ranged from 1.8 to 36.8+ months in ROS1-positive and metastatic NSCLC.
GSK announces positive EAGLE-1 results for gepotidacin in gonorrhoea treatment
Boehringer Ingelheim reports strong growth in 2023 and accelerates late-stage pipeline
Charles River Laboratories launches AMAP to reduce animal testing reliance
PureTech completes enrollment in Phase 2b ELEVATE IPF trial for LYT-100
Cybin secures additional US patent for CYB003 breakthrough therapy programme
GSK's meningitis vaccine candidate accepted for FDA review
Innovent Biologics names new Oncology CMO
UroGen's UGN-103 IND accepted by FDA for bladder cancer treatment
Biophytis reinforces obesity IP with new patent application
MaaT Pharma reveals positive 18-month data for MaaT013 in GI-aGvHD
Fusion Antibodies plc secures contract for OptiPhage library development
Innate Pharma advances Sanofi-developed NK cell engager to Phase 2 for blood cancer patients
AbbVie announces interim evaluation of Atogepant Phase three, open-label 156-week extension study