FDA approves Rozlytrek™ for cancer patients with ROS1-positive & NTRK
Category: #health  By Sunil Hebbalkar  Date: 2019-08-17
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FDA approves Rozlytrek™ for cancer patients with ROS1-positive & NTRK

FDA approves Rozlytrek™ for cancer patients with ROS1-positive & NTRK

Rozlytrek™ will be Roche’s first FDA approved medicine that targets genetically mutilated cancer as well as both ROS1 and NTRK fusions.

Roche Holding AG, a Swiss pharmaceutical company, has recently announced that the U.S. Food and Drug Administration (FDA) has given approval to Rozlytrek™ (entrectinib) to treat adults suffering from ROS1-positive, metastatic non-small cell lung cancer (NSCLC).

According to reports, the FDA has authorized Rozlytrek to treat adults and pediatric patients above 12 years of age with solid tumors that contain an NTRK (neurotrophic tyrosine receptor kinase) gene fusion with an unknown origin of resistance mutation, which is metastatic or has progressed during treatment or has no satisfactory alternative therapy.

As per reliable sources, the combined analysis of the pivotal Phase I STARTRK-1, Phase I ALKA-372-001 trials and Phase II STARTRK-2 and information from the Phase I/II STARTRK-NG study have played a significant role in getting an approval from the FDA.

In the integrated analysis, Rozlytrek was examined in various solid tumor types, including cholangiocarcinoma, breast, gynecological, colorectal, non-small cell lung, neuroendocrine, pancreatic, salivary gland, thyroid cancers and sarcoma.

However, in ROS1-positive, metastatic NSCLC, Rozlytrek reduced tumors in 78% of patients suffering from the disease and the DoR (duration of response) ranged from 1.8 to 36.8+ months. Rozlytrek also lowered tumors in more than half of patient suffering from NTRK gene fusion-positive, metastatic solid tumor or locally advanced, while objective results were witnessed across 10 types of tumor with a DoR ranging from 2.8 to 26.0+ months.

According to Sandra Horning, MD, Chief Medical Officer & Head of Global Product Development, Roche, the FDA approval for Rozlytrek for treating two key types of cancer is great news for patients. She claims that Rozlytrek is the first treatment by the company that has gained FDA’s approval for treating both NTRK fusions and ROS1, while showing significant response in rare cancer types that have reached patient’s brain.

Source Credit: https://www.globenewswire.com/news-release/2019/08/16/1902884/0/en/FDA-approves-Roche-s-RozlytrekTM-entrectinib-for-people-with-ROS1-positive-metastatic-non-small-cell-lung-cancer-and-NTRK-gene-fusion-positive-solid-tumours.html



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Sunil Hebbalkar

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Sunil Hebbalkar

Sunil Hebbalkar develops content for Algosonline, Market Size Forecasters, and a couple of other platforms. A Post graduate mechanical design engineer by qualification, he worked as an intern at the defense lab for one year in the engine design and development departm...

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