Bayer's Tumor-Agnostic TRK Inhibitor Larotrectinib Approved in China for NTRK Fusion-Positive Solid Tumors

On April 13, the official website of the National Medical Products Administration (NMPA) announced that Bayer's Larotrectinib Sulfate Capsules have been approved for marketing in China. The drug is indicated for the treatment of adult and pediatric patients with solid tumors harboring Neurotrophic Tyrosine Receptor Kinase (NTRK) fusion genes.

Larotrectinib was initially discovered by Array BioPharma (which has been acquired by Pfizer), licensed to Loxo Oncology (which has been acquired by Eli Lilly) in 2013, and partnered with Bayer in 2017. In November 2018, it was first launched in the United States for NTRK fusion-positive solid tumors, after having been granted Breakthrough Therapy designation by the FDA, and subsequently launched in Europe and Japan. Larotrectinib is a first-generation TRK inhibitor and the first drug to be launched based on a biomarker.

Data Source: NextPharma® - Transactions & Rights

Bayer disclosed long-term follow-up data from three trials (NCT02122913, NCT02576431, and NCT02637687) of larotrectinib for the treatment of TRK fusion-positive tumors. As of July 15, 2019, among 116 adult patients with 17 types of tumors, the ORR reached 71%, and the ORR in patients with brain metastases was 71%; at a median follow-up of 17.4 months, the mDOR was 35.2 months; at a median follow-up of 14.6 months, the mPFS was 25.8 months; and the 12-month OS was 87%.