Roche gets FDA nod for 'Rozlytrek' treatment
By Josh White
Date: Friday 16 Aug 2019
(Sharecast News) - Roche announced on Friday that the US Food and Drug Administration (FDA) has approved 'Rozlytrek' (entrectinib) for the treatment of adults with ROS1-positive, metastatic non-small cell lung cancer (NSCLC).
The Swiss pharmaceuticals giant said the FDA had also granted accelerated approval to Rozlytrek for the treatment of adult and paediatric patients 12 years of age and older with solid tumours that had a neurotrophic tyrosine receptor kinase (NTRK) gene fusion, without a known acquired resistance mutation, were metastatic or where surgical resection was likely to result in severe morbidity, and had progressed following treatment or had no satisfactory alternative therapy.
It said the approvals were based on results from the integrated analysis of the pivotal phase 2 'STARTRK-2', phase 1 'STARTRK-1' and phase 1 'ALKA-372-001' trials, and data from the phase 1 and 2 'STARTRK-NG' study.
In the integrated analysis, Rozlytrek was studied in several solid tumour types, including breast, cholangiocarcinoma, colorectal, gynaecological, neuroendocrine, non-small cell lung, salivary gland, pancreatic, sarcoma and thyroid cancers.
Roche said that in ROS1-positive, metastatic NSCLC, Rozlytrek shrank tumours in 78% of people with the disease, and the duration of response ranged from 1.8 to at least 36.8 months.
Rozlytrek also shrank tumours in more than half of people with NTRK gene fusion-positive, locally advanced or metastatic solid tumours, with objective responses observed across 10 tumour types with the duration of response ranging from 2.8 to at least 26.0.
Objective responses to Rozlytrek were seen in people with central nervous system metastases at baseline.
"Rozlytrek's FDA approval for two rare types of cancer is an important advance for patients, combining a targeted medicine and genomic testing to bring this new treatment option to patients who are waiting," said Roche's chief medical officer and head of global product development, Sandra Horning.
"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."
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