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European approval of Roche’s first tumor diagnostic …

It is approved for people with NTRK gene fusion-positive cancer tumors and for people with ROS1-positive advanced non-small cell lung cancer (NSCLC).

Roche’s first tumor diagnostic cancer treatment, Rozlytrek, is now approved in Europe. The treatment has previously been approved in the United States.

The fact that the treatment is tumor-agnostic means that patients with NTRK gene fusion-positive cancer can receive treatment based on genetic changes specific to their tumor, regardless of which organ the tumor originates in.

– NTRK gene fusions have reviewed cancer, and studies have shown the effect of Rozlytrek regardless of where the tumor occurred, including in patients with spread to the brain. Rozlytrek can also be used for patients with non-small cell lung cancer with ROS1

gene changes, says Karsten Bruins Slot, medical director of Roche Norway.

The presence of NTRK gene fusion or ROS1 mutation must be determined before starting treatment with Rozlytrek. Both ROS1 and NTRK gene changes are rare, and we assume that 1-2% of patients with non-small cell lung cancer are ROS1-positive and approximately 0.3% of all solid tumors are NTRK-positive.

– To find these patients, one must use a validated molecular diagnostic test, such as sequencing. The European Commission’s approval of Rozlytrek demonstrates the value of combining genomic profiling with precision medicine to offer patients with rare and challenging cancers a personalized treatment option. Now it is important that we quickly deploy the next generation sequencing (NGS) as a routine diagnosis for Norwegian cancer patients with spread, Bruins Slot explains.

NGS is the collective term for a number of revolutionary technologies that make it possible to map an individual’s genes very quickly. Although it previously took up to a year to map such a genome, today it takes less than 24 hours. And even before there were only a few large sequencing centers in the world that could do the job, it is today possible for most laboratories in hospitals.

Method evaluations for Rozlytrek in Norway, both for patients with NTRK and ROS1 indication, are currently being evaluated by the Norwegian Medicines Agency. Roche hopes that the treatment can be used in Norway in a few months.

– This method evaluation differs somewhat from the method evaluations both we and the Norwegian Medicines Agency are used to, partly due to the fact that there are very rare genetic changes across a number of different cancers, and therefore there is limited documentation. We are therefore pleased that the report on the introduction of precision medicine has been resumed, and we want to continue the dialogue with the authorities and find solutions together, so that Norwegian patients have quick access to the most optimal diagnostics and personal treatment, says Bruins Slot.

About the approval:

European Commission has granted conditional marketing authorization for Rozlytrek® (entrektinib) for the treatment of adults and children aged 12 years and older with solid tumors expressing a neurotrophic tyrosine receptor kinase (NTRK) gene fusion, with a locally advanced metastatic disease or Surgical resection likely to lead to severe morbidity and who have not received a previous NTRK inhibitor, which does not have satisfactory treatment options.

The European Commission has also approved Rozlytrek for the treatment of adults with ROS1-positive, advanced non-small cell lung cancer (NSCLC) who have not been previously treated with ROS1 inhibitors. The approval is based on results from the integrated analysis of the pivotal phase II STARTRK-2, phase I STARTRK-1 and phase I ALKA-372-001 study and data from the phase I / II STARTRK-NG study.

More information can be found in Roche’s global press release.

About Roche

Roche is a global player in medicine and diagnostics with a focus on developing science to improve people’s lives. The combined strength of having medicines and diagnostics under one roof has made Roche a leading healthcare company – a strategy that aims to tailor the right treatment to each patient in the best possible way.

Roche is the world’s largest biotechnology company with differentiated drugs in oncology, immunology, infectious diseases, eye diseases and diseases of the central nervous system. Roche is also a world leader in in vitro diagnostics and tissue-based cancer diagnostics and a pioneer in diabetes treatment.

Roche was founded in 1896 and continues to work to prevent, diagnose and treat diseases and contribute to a sustainable society. The company strives to improve patients’ access to medical innovations by collaborating with all relevant stakeholders. More than thirty medicines developed by Roche are included in the World Health Organization’s list of important medicines, including life-saving antibiotics, antimalarials and cancer medicines. In addition, for 11 years in a row, Roche has been recognized as one of the most sustainable companies in the healthcare sector by the Dow Jones Sustainability Indices (DJSI).

The Roche Group, headquartered in Basel, Switzerland, operates in over 100 countries and employed approximately 98,000 people worldwide in 2019. In 2019, Roche invested CHF 11.7 billion in research and development and had sales of CHF 61.5 billion. Genentech, in the USA, is a wholly owned company in the Roche group. Roche is the majority owner of Chugai Pharmaceutical, Japan. For more information, visit www.roche.com.

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