The company has also received accelerated approval for Rozlytrek to treat adult and paediatric patients 12 years of age and older with solid tumours, which have a neurotrophic tyrosine receptor kinase (NTRK) 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 block ROS1 and NTRK kinase activity and may result in the death of cancer cells with ROS1 or NTRK gene fusions.
The approvals are 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, as well as data from the phase I/II STARTRK-NG study.
In the integrated analysis, Rozlytrek was assessed in various solid tumour types such as breast, cholangiocarcinoma, colorectal, gynaecological, neuroendocrine, non-small cell lung, salivary gland, pancreatic, sarcoma and thyroid cancers.
According to the company, Rozlytrek shrank tumours in 78% 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.
Foundation Medicine is also planning to submit FoundationOne CDx to the FDA for approval as a companion diagnostic for Rozlytrek, as currently there is no FDA-approved companion diagnostic for Rozlytrek.
Rozlytrek’s safety was evaluated from an integrated analysis of 355 people across the four trials, which enrolled people across 15 countries and over 150 clinical trial sites.
Roche chief medical officer and global product development head Dr Sandra Horning said: “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.
“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.”
In May this year, Roche received approval from the FDA for its Venclexta (venetoclax) in combination with Gazyva (obinutuzumab) to treat people with previously untreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).