Roche’s personalized cancer treatment wins FDA approval

FILE PHOTO: The logo of Swiss pharmaceutical company Roche is seen outside the Shanghai Roche Pharmaceutical Co. Ltd. headquarters in Shanghai May 22, 2014. REUTERS/Aly Song

(Reuters) – The U.S. Food and Drug Administration approved Roche Holding AG’s treatment for adult and adolescent patients whose cancers have a genetic defect, the agency said on Thursday.

The treatment, Rozlytrek, is a tyrosine kinase inhibitor that targets patients who must be identified via genetic profiling. The treatment is used to treat certain types of solid tumors and a type of lung cancer.

Genetic profiling is a form of personalized treatment, where patients are identified via a biomarker test, and is a departure from treating them based on where the tumor occurred in the body.

Rozlytrek aims to treat rare genetic anomalies called NTRK fusions. These anomalies are tumor-agnostic, meaning they are present in tumors irrespective of the site of origin.

Individually, the mutations are so rare that cancer units are seen as unlikely to run dedicated tests for each.

Since these NTRK fusions occur in a multitude of tumors, Roche sees potentially broad application for Rozlytrek, in conjunction with diagnostic tests from its Foundation Medicine unit.

In June, Rozlytrek won approval in Japan to treat NTRK fusions.

Rival treatment Vitrakvi from German drugmaker Bayer has already won U.S. backing for solid tumors that test positive for NTRK genes.

Reporting by Aakash Jagadeesh Babu and Manojna Maddipatla in Bengaluru; Editing by Arun Koyyur

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