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Roche: FDA Grants Priority Review To Entrectinib

Swiss drug major Roche Holding AG (RHHBY) said Tuesday that the U.S. Food and Drug Administration has accepted the company's New Drug Applications or NDAs and granted Priority Review for the company's personalised medicine entrectinib.

Entrectinib was granted priority review for the treatment of adult and paediatric patients with neurotrophic tropomyosin receptor kinase or NTRK fusion-positive, locally advanced or metastatic solid tumours who have either progressed following prior therapies or as an initial therapy when there are no acceptable standard therapies, and for the treatment of people with metastatic, ROS1-positive non-small cell lung cancer or NSCLC.

These NDAs 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 as well as data from the Phase I/Ib STARTRK-NG study. The FDA is expected to make a decision on approval by 18 August 2019.

Sandra Horning, Roche's Chief Medical Officer and Head of Global Product Development, said, "By combining comprehensive genomic profiling with actionable targeted therapies, like entrectinib, we are advancing our personalised healthcare goal to find the right treatment for each patient. We are working closely with the FDA to make this potential new option available as soon as possible."

The FDA grants Priority Review to medicines determined to have the potential to provide significant improvements in the treatment, prevention or diagnosis of a serious disease.

Entrectinib was also granted Breakthrough Therapy Designation or BTD by the US Food and Drug Administration; Priority Medicines or PRIME designation by the European Medicines Agency or EMA; and Sakigake designation by the Japanese health authorities for the treatment of NTRK fusion-positive, locally advanced or metastatic solid tumours in adult and paediatric patients who have either progressed following prior therapies or have no acceptable standard therapies.

BTD is designed to expedite the development and review of medicines intended to treat serious or life-threatening diseases and to help ensure people have access to them through FDA approval as soon as possible.

According to Roche, results from the integrated analysis showed entrectinib shrank tumours or ORR in more than half, or 57.4 percent of people with NTRK fusion-positive solid tumours. Objective responses to entrectinib were seen across 10 different solid tumour types, including in people with and without CNS metastases at baseline.

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