Broad-spectrum anticancer drug --- Serpatinib

Another targeted therapy drug has officially achieved "broad-spectrum anti-cancer"! In recent years, multiple targeted immunotherapy drugs have begun to challenge the broad-spectrum anti-cancer indications of "solid tumors". The corresponding indications have been approved based on TMB, MSI, NTRK1/2/3, and BRAF! The sixth broad-spectrum indication not limited to cancer is here.
On September 22, 2022, the FDA accelerated the approval of selpercatinib (Selpatinib Retevmo), which is used for patients with advanced or metastatic RET fusion solid tumors after failure of systemic therapy.
Broad Spectrum Anticancer Drugs
In May 2017, pembrolizumab was approved by the US FDA for patients with solid tumors with microsatellite instability-high (MSI-H) or mismatch repair deficiency (dMMR), regardless of the tumor source, becoming the first in the world Immunopharmaceuticals that do not differentiate tumor origin.
In November 2018, larotrectinib was approved by the US FDA for the treatment of adult and pediatric solid tumors with neurotrophic receptor tyrosine kinase (NTRK) gene fusion.
In August 2019, Entrectinib was granted accelerated approval by the FDA for the treatment of adult and pediatric patients with neurotrophic myosin receptor kinase (NTRK) fusion-positive, locally advanced or metastatic solid tumor progression after initial treatment or Patients with solid tumors without standard treatment options, and patients with ROS1-positive non-small cell lung cancer (NSCLC).
In June 2020, the second new indication of "unlimited cancer types" for pembrolizumab was approved. For the treatment of adult and pediatric patients with unresectable or metastatic solid tumors with a high tissue tumor mutation burden (TMB-H) ≥10 mutations/Mb (using an FDA-specified assay).
On June 23, 2022, dabrafenib combined with trametinib was approved by the U.S. FDA for accelerated approval by the U.S. FDA for children and adults aged 6 years and older with BRAF V600E mutations, unresectable or metastatic solid tumors. Progression after treatment and no other treatment options.
Among them, two broad-spectrum anticancer drugs have been approved in China!
On April 13, 2022, China's NMPA approved the launch of the targeted drug Larotrectinib Sulfate Capsules (trade name: Weitaikai), which is used for the treatment of NTRK gene fusions diagnosed by well-validated detection methods and no known acquired resistance. Drug mutation, locally advanced, metastatic or surgical resection may lead to serious complications, no satisfactory alternative treatment options or previous treatment failure of adult and pediatric patients with pan-solid tumors. China ushered in the first pan-solid tumor targeted drug that has nothing to do with tumor/tissue: larotrectinib.
On July 29, 2022, Roche Pharmaceuticals' Entrectinib (Entrectinib) was officially approved by the National Medical Products Administration (NMPA), and it is suitable for the diagnosis of neurotrophic tyrosine receptor kinase (Neurotrophic tyrosine receptor kinase (NTRK) fusion gene and does not include known acquired resistance mutations, adults and 12 years old with locally advanced, metastatic disease or surgical resection may cause serious complications, and no satisfactory alternative therapy or failure of previous therapy and above children with solid tumors.
On September 22, 2022, the U.S. FDA accelerated the approval of selpercatinib (Selpatinib Retevmo), which is used for patients with advanced or metastatic RET fusion solid tumors after failure of systemic therapy, becoming the sixth molecular marker-based but not limited Approved indications for cancer types! At the same time, Serpatinib is also the first precision therapy approved specifically for the treatment of solid tumors carrying RET gene mutations.