2019-08-21| Trials & Approvals

Rozlytrek Becomes the Third Tumor-Agnostic Medicine to be Approved by the USFDA

by Rajaneesh K. Gopinath
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By Rajaneesh K. Gopinath, Ph.D.

After Merck and Co’s Keytruda and Bayer and Loxo Oncology’s Vitrakvi, Roche’s Rozlytrek (Entrectinib) bags USFDA approval as an oncology therapy, that is not specific to any type of cancer originating in an organ but based on a common biomarker across different types of tumors.

Personalized medicine is no more just an idea but a reality in modern healthcare, especially in field of cancer therapy. Keytruda (Pembrolizumab) was the first approved tumor-agnostic medicine, but was previously used for treating several specific tumor types. Therefore, Vitrakvi (Larotrectinib) became the first treatment with this indication at the time of initial FDA approval. Last week, Roche announced the approval of its selective tyrosine kinase inhibitor, Rozlytrek for the treatment of adults with ROS1-positive, metastatic non-small cell lung cancer (NSCLC). With this, the drug became Roche’s first but overall the third tumor-agnostic oncology therapy. Roche has priced Rozlytrek, at about $17,050 per month which is approximately half as that of Vitrakvi’s.

The FDA has also granted accelerated approval to Rozlytrek for the treatment of solid tumors in adult and pediatric patients who harbor a neurotrophic tyrosine receptor kinase (NTRK) gene fusion without a known acquired resistance mutation and have no successful alternative treatments. Last June, Japan’s Ministry of Health, Labour and Welfare (MHLW) approved the kinase inhibitor for the same indication. Rozlytrek results in cancer cell death by blocking ROS1 and NTRK kinase activity in cells that harbor ROS1 or NTRK gene fusions.


Integrated Analysis of Pivotal Phase I/II Trials

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 trials, and data from the Phase I/II STARTRK-NG study. The integrated analysis took into account, the results all the above-mentioned studies where Rozlytrek was tested in solid tumors. In ROS1-positive, metastatic NSCLC, Rozlytrek shrank tumors in 78% of patients (overall response rate [ORR]; N=51) and the duration of response (DoR) ranged from 1.8 to 36.8+ months (N=40 out of 51). In the case of patients with NTRK gene fusion-positive, locally advanced or metastatic solid tumors, the ORR was 57% (N=54), and objective responses were observed across 10 tumor types (DoR ranged from 2.8 to 26.0+ months; N=31 out of 54). Adverse reactions included fatigue, constipation, dysgeusia, edema, dizziness, diarrhea, nausea, dysaesthesia, dyspnea, myalgia, cognitive impairment, increased weight, cough, vomiting, fever, joint pain and vision disorders. An FDA-approved companion diagnostic for Rozlytrek is not available at the present time but Foundation Medicine will submit FoundationOne®CDx to the FDA for approval.

“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,” said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. “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.”




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