Roche's "unlimited cancer" treatment, Rozlytrek, has been approved by the European Union.

Read: Rozlytrek has a long-lasting response to a variety of NTRK gene fusion-positive solid tumors.
August 3, Roche announced that the European Commission (EC) had granted Rozlytrek (entrectinib) conditional listing permits for adult and pediatric patients with neurotrophic tyrosine receptor kinase (NTRK) gene fusion 12 years of age and older who have locally advanced, metastatic solid tumors or surgical removals that can lead to serious complications, and have not received NTRK inhibitor sthem and have no satisfactory treatment options.
also approved Rozlytrek for active non-small cell lung cancer (NSCLC) adult patients who had not previously been treated with ROS1 inhibitors.
previously, Rozlytrek has been awarded the European Medicines Agency's priority drug program for adult and pediatric patients with NTRK fusion-positive locally advanced or metastatic solid tumors.
understand that this approval is based on the combined analysis results of STARTRK-2, Phase 1 clinical studies STARTRK-2 and Phase 1 clinical studies, as well as the data of startRK-NG in Phase 1 clinical studies.
the studies were recruited in 15 countries and more than 150 clinical trial sites, and the safety and efficacy of Rozlytrek was assessed through a comprehensive analysis of 504 people in the four trials.
studies have shown that Rozlytrek has a long-lasting response to a variety of NTRK gene fusion-positive solid tumors, including sarcoma, NSCLC, salivary breast-like secretion cancer (MASC), secreted and non-secreting breast cancer, thyroid, colorectal, neuroendocrine, pancreas, ovaries, endometrial cancer, bile duct cancer, gastrointestinal tumors and neuroblastomas, and ROS1-positive NSCLC.
analysis of specific results showed that in NTRK fusion-positive, locally advanced or metastatic solid tumor patients, Rozlytrek reduced the tumor of more than half of the patients (ORR s 63.5; N?74) and observed an objective reaction in 14 tumor types (average reaction duration (DoR) s 12.9 months (9.3 months - not reached), 21 of the 47 patients defined by N-ORR).
in ROS1-positive patients with advanced NSCLC, Rozlytrek reduced tumors by 73.4% of patients (ORR; N s 94, at least 12 months of follow-up), with an average DoR of 16.5 months (14.6-28.6 months).
of 161 patients who followed for at least six months, including 29 percent of patients with central nervous system (CNS) metastasis, with an ORR of 67.1 percent.
observed an objective response to Rozlytrek in patients with central nervous system metastasis, with 62.5% and 77.8% intracranial ORR in patients with NTRK and ROS1 gene changes, respectively.
in pediatric patients, Rozlytrek reduced the tumors of all children and adolescents with NTRK gene fusion (N-5) (shown on the ORR), two of whom received full remission (CR).
two advanced cancer patients originally born with CNS had an objective response, one of whom had CR.
currently found NTRK gene fusion in a range of solid tumor types and is expressed in more than 90 percent in some rare cancers, but less than 1 percent in some common tumors such as lung and colorectal cancer.
NTRK fusion-positive tumors occur when the NTRK1/2/3 gene fuses with other genes, which causes a change in the TRK protein and activates the signaling pathways involved in the proliferation of certain types of cancer.
NTRK gene fusion is present in tumors, independent of the tumor's origin tissue organs.
ROS1 is a tyrosine kinase that plays an important role in controlling cell growth and proliferation.
when the ROS1 gene fusion occurs, cancer cells grow and multiply in an uncontrolled manner.
blocking this abnormal signal can cause tumor cells to shrink or die.
ROS1 gene fusion occurs in 1% to 2% of NSCLC patients.
NTRK and ROS1 gene fusion using biomarker testing is the most effective method to determine who is most qualified for Rozlytrek treatment.
it is understood that Roche is developing an auxiliary diagnostic method to help identify patients with the NTRK and ROS1 gene fusion.
Rozlytrek is a selective tyrosine kinase inhibitor designed to inhibit kinase activity of TRKA/B/C and ROS1 proteins, whose activation fusion promotes the proliferation of certain types of cancer.
the drug was approved by the U.S. FDA in August 2019 for the treatment of adult and pediatric solid tumor patients 12 years and older, as well as ROS1-positive adult metastatic NSCLC.
June 2019, Japan's Ministry of Health, Labour and Welfare approved Rozlytrek's treatment of NTRK-positive, advanced recurrent solid tumor sorority in adults and pediatric patients, and in February 2020 approved the drug for ROS1-positive NSCLC.
so far, Rozlytrek has also received approval from health regulators in Australia, Canada, Israel, New Zealand and South Korea.
Source: Rozlytrek, Roche's First-agnostic therapy, approved in Europe for people with NTRK fusion-positive solids and for people with ROS1-positive advanced non-small cell cancer.