The Center of Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) approved Bayer’s larotrectinib, under the brand name Vitrakvi, for the treatment of adult and pediatric patients with advanced solid tumors that harbor a Neurotrophic Tyrosine Receptor Kinase (NTRK) gene fusion. NTRK gene fusions should be identified by a sufficiently validated test.
Larotrectinib is a first-in-class, highly selective TRK inhibitor exclusively designed to treat solid tumors that have an NTRK gene fusion, also known as TRK fusion solid tumors. This precision oncology treatment has demonstrated high response rates, durable responses and a favorable safety profile in adults and children with TRK fusion solid tumors, Bayer explained in its press release.
Vitrakvi is already approved in the U.S., Japan, countries of the European Union (EU), the UK and other markets around the world.
“These clinically meaningful high response rates and durable responses as well as the favorable safety profile seen in larotrectinib trials involving patients from China and worldwide, support its efficacy and safety in adults and children,” said Prof. Xu Ruihua, MD, PhD, President of Sun Yat-sen University Cancer Center. “A high unmet need remains for new and innovative cancer treatments in China. Advancements in precision therapies, like larotrectinib, demonstrate the importance of comprehensive genomic testing to uncover actionable oncogenic drivers and identify patients most likely to benefit from a targeted treatment approach.”
“The approval of larotrectinib in China represents a meaningful advancement in cancer care with a highly innovative treatment option that addresses the genomic alteration driving solid tumor growth, regardless of the location where the tumor originates,” said Christine Roth, Member of the Executive Committee of Bayer’s Pharmaceuticals Division and Head of Bayer’s Oncology Strategic Business Unit. “This approval further demonstrates Bayer’s commitment to delivering next-generation precision medicines to appropriate patients and clinicians.”
The approval of larotrectinib in China is based on data from the Phase I trial of adult patients, the Phase II NAVIGATE trial in adult and adolescent patients and the Phase I/II pediatric SCOUT trial. In these trials, larotrectinib was investigated across more than 20 different histologies of solid tumors including lung cancer, thyroid cancer and colorectal cancer as well as salivary gland cancer and soft tissue sarcomas including infantile fibrosarcoma and gastrointestinal stromal tumors. The compound has shown powerful efficacy with high response rates and durable responses as well as a favorable safety profile across tumor types in adults and children with TRK fusion solid tumors. The clinical activity has been shown across multiple tumor types including primary central nervous system (CNS) tumors and brain metastases, the company said.
TRK fusion cancer is rare overall. It affects both children and adults and occurs in varying frequencies across various tumor types. TRK fusion cancer occurs when an NTRK gene fuses with another unrelated gene, producing a chimeric TRK protein. The altered protein, or TRK fusion protein, becomes constitutively active or overexpressed, triggering the activation of an intercellular signaling cascade leading to tumor growth and spread.
Bayer noted that Larotrectinib will be available in China in oral capsules for adults and children. The CDE of China’s NMPA is currently reviewing its regulatory application as a liquid formulation.