Roche has announced the US Food and Drug Administration (FDA) approval of Rozlytrek (entrectinib) for the treatment of adults with ROS1-positive, metastatic non-small cell lung cancer (NSCLC).
The governing body also granted accelerated approval to Rozlytrek for the treatment of adult and paediatric patients 12 years of age and older with certain solid tumours that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion.
The approvals are based on results 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, which found that Rozlytrek shrank tumours in 78% of people with ROS1-positive, metastatic NSCLC and also shrank tumours in more than half of people with NTRK gene fusion-positive, locally advanced or metastatic solid tumours.
Objective responses were observed across ten tumour types and were also seen in people with central nervous system (CNS) metastases at baseline.
Sandra Horning, Roche’s chief medical officer said that the FDA approval is an “important advance” for patients, “combining a targeted medicine and genomic testing to bring this new treatment option to patients who are waiting.”
She went on to explain that “Rozlytrek is the first FDA-approved treatment that selectively targets both ROS1 and NTRK fusions, and, importantly, has also shown responses in these rare cancer types that have spread to the brain.”
The FDA’s Accelerated Approval Program allows conditional approval of a medicine that fills an unmet medical need for a serious or life-threatening disease or condition. The accelerated approval for NTRK gene fusion-positive solid tumors is based on tumour response rate and durability of response, and continued approval may be contingent upon verification and description of clinical benefit in the confirmatory trials.