On August 27, 2018 Bayer reported that it has filed an application for approval for larotrectinib with the European Medicines Agency (EMA) (Press release, Bayer, AUG 27, 2018, View Source [SID1234529076]). Larotrectinib has been developed for the treatment of patients (adults and children) with locally advanced or metastatic solid tumors with a fusion in the neurotrophic tyrosine receptor kinase (NTRK) genes. NTRK gene fusions are changes in the genome that result in uncontrolled production of tropo-myosin receptor kinase (TRK) receptor fusion proteins and tumor growth.
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Larotrectinib is a highly selective TRK inhibitor. It acts purposefully against TRK fusion proteins, regardless of where in the body of a patient the cancer has developed. Bayer and Loxo Oncology, a biopharmaceutical company based in Stamford, Connecticut, USA, are developing larotrectinib together. In May 2018, the US Food and Drug Administration (FDA) approved the accelerated approval process for larotrectinib in the indication "Treatment of adults and children with locally advanced or metastatic solid tumors in which a NTRK gene fusion has been detected".
"Larotrectinib has achieved significant clinical success in patients with TRK fusion tumors, and the effect has been rapid and sustained, as has been observed in various types of tumors in both adults and children," said PD. Ulrik Lassen from the oncology department of Rigshospitalet in Copenhagen.
"The approval of larotrectinib would be a paradigm shift in cancer treatment, targeting the change in the genome that promotes cancerous growth, regardless of where in the body the cancer occurred." Scott Fields, Senior Vice President and Head of Oncology Development at Bayer. "The approval application for larotrectinib brings us one step closer to our goal of providing a much-needed treatment option in Europe for cancer patients with TRK fusion tumors."
About Larotrectinib (LOXO-101)
Larotrectinib (LOXO-101) is a potent, orally-to-be, selectively-acting new investigational drug currently in clinical development for the treatment of patients with a variety of cancers that have tropomyosin receptor kinase (TRK) abnormalities. play a role. Numerous studies suggest that the neurotrophic tyrosine receptor kinase genes (NTRK genes), which code for TRK and normally have major functions in the nervous system, may undergo abnormal fusions with other genes. This leads to growth signals that can cause cancer in numerous other areas of the body.
In clinical studies with patients presenting various types of solid tumors with NTRK gene fusions, larotrectinib showed an investigator-determined overall response rate (ORR) of 80 percent and an ORR of 75 percent, as confirmed by independent review. Larotrectinib was well tolerated with most of the adverse events reported being grade 1 or 2.
In November 2017, Bayer and Loxo Oncology announced that they would jointly develop and market the active ingredients larotrectinib and LOXO-195, another novel TRK inhibitor. Outside the US, Bayer will oversee regulatory activities and global marketing activities. Bayer and Loxo Oncology will jointly distribute the product in the United States. Loxo Oncology remains responsible for ongoing clinical trials and regulatory activities in the United States.
More information about the clinical trials with Larotrectinib or LOXO-195 can be found at www.clinicaltrials.gov or on the website www.loxooncologytrials.comavailable. Larotrectinib and LOXO-195 are not approved by the US Food and Drug Administration (FDA), the European Commission or other health authorities.
About TRK fusion cancer
TRK fusion cancer is due to NTRK gene fusions. These are chromosomal mutations that occur when one of the neurotrophic tyrosine receptor kinase (NTRK) genes binds abnormally to another, non-contiguous gene and results in an aberrant NTRK gene. The translated abnormal protein, or TRK fusion protein, is continuously active and this can lead to uncontrolled and possibly cancer-causing cell communication. These proteins are the major driver for the development and spread of tumors in patients with TRK fusion tumors. TRK fusion tumors can occur anywhere in the body because they are not bound to specific cell or tissue types. NTRK gene fusions occur in a variety of solid tumors in both adults and children. These include carcinoma of the appendix, breast cancer, bile duct carcinoma, colon cancer, GIST (gastrointestinal stromal tumors), fibrosarcoma in children, lung cancer, mammary analogue secretory carcinoma (MASC) of the salivary glands, melanoma, pancreatic cancer, thyroid cancer and various sarcomas. A TRK fusion tumor can only be diagnosed using sensitive and specific tests. Next generation sequencing (NGS) can provide a comprehensive view of the genomic changes in a variety of genes. Fluorescence in situ hybridization (FISH) and polymerase chain reaction (PCR) -based assays, on the other hand, are more suitable for highly targeted analysis because of their lower multiplex ability, while immunohistochemistry (IHC) is based on detection of the TRK protein.trkcancer.com/.
About Oncology at Bayer With the goal of improving people’s lives, Bayer is working to expand its portfolio of innovative treatments. Bayer’s Oncology division includes four approved compounds as well as other compounds in various stages of clinical development. All of these products reflect the company’s research approach, which focuses on the search for appropriate cancer targeting targets.