Share on facebook
Facebook
Share on twitter
Twitter
Share on linkedin
LinkedIn
Share on whatsapp
WhatsApp

We Are Proud To Be At the Forefront of Personalized Medicine to Update You on This Novel Cancer Drug Approval

About the approval, the studies and the drug, entrectinib –

The first regulatory approval has been granted to entrectinib (Rozlytrek) in Japan for the treatment of adult and pediatric patients with NTRK fusion–positive, advanced recurrent solid tumors.

4 studies – 3 in adult and 1 in pediatric and adolescent patients – using this novel drug, enrolled patients across 15 countries and 150 clinical trial sites. Findings from an integrated analysis of the 3 studies in adults demonstrated a 57.4% response – percentage of patients who experienced disease shrunk or stopped – in patients with NTRK fusion–positive solid tumors and the median duration of response was 10.4 months. Among patients with brain metastases, the response was 50%.

In the studies, tumor types included breast cancer, cholangiocarcinoma, colorectal cancer, gynecological cancer, neuroendocrine tumors, NSCLC, salivary gland cancer, pancreatic cancer, sarcoma and thyroid cancer.

More than 40% of the patients had received ≥2 or more prior lines of therapy, and 37% had untreated cancers.

The dose of entrectinib was set to be 400 mg/m2 daily.

Regarding safety, adverse events (AEs) with entrectinib were consistent with that seen in prior studies. The most commonly reported AEs included fatigue, constipation, dysgeusia, edema, dizziness, diarrhea, nausea, dysesthesia, dyspnea, pain, anemia, cognitive disorders, weight increased, vomiting, cough, blood creatinine increase, arthralgia, pyrexia and myalgia.

The future with entrectinib –

Japanese regulatory authorities are also in the process of reviewing a potential indication for entrectinib for the treatment of patients with ROS1 fusion–positive locally advanced or metastatic non–small cell lung cancer (NSCLC).

Additionally, the pooled findings from the 3 studies on adults showed that entrectinib demonstrated a 77.4% response and a median duration of response of 24.6 months in patients with locally advanced or metastatic ROS1-positive NSCLC.

The FDA is expected to decide on the application for the use in patients with NTRK fusion–positive solid tumors by August 18, 2019.

In the international, multicenter, open-label, ongoing trial, investigators are enrolling 300 patients with solid tumors that harbored an NTRK1-/2-/3-, ROS1- or ALK-positive fusion.

It is worth asking your oncologist and not giving up – this innovative and advanced treatment can change your life!

The best treatment for a cancer patient is to get the most advanced cancer drugs in advanced stages of development. There, the hope and the chance to extend life go far beyond the standard protocols.

TRIAL•IN Pharma
Do not give up on life!
Contact us 24/7 for free service matching:
Call center +44.2082.426.039
www.trial-in.com

For further reading

To get a personal free assessment to our service please in fill in your details and we will get back to you shortly

Improve therapeutic outcomes, prolong life and quality of life are our main business. We support access to and expand cancer treatments beyond the standard of care, with the most advanced and innovative treatment options in the world, personally matching the individual cancer patient’s medical condition and with the support of top tier oncologists.

Article categories

קטגוריות המאמרים

Popular topics

Close Menu