Here’s the list of latest anticancer drugs in the market.
Epacadostat is undoubtedly a bright star in the IDO field. The results of clinical trials show that the combination of IDO inhibitors and programmed death receptor 1 (PD-1) monoclonal antibody has some advantages over PD-1 alone. anti. Incyte has reached a cooperation agreement with the two giants of PD-1 monoclonal antibody Merck and BMS, and also extensively explored the combined function of Epacadostat and other immune checkpoint inhibitors. The indications also cover multiple cancer categories, but Incyte seems Not content with this, their every move has attracted much attention. Incyte purchased the global development and commercial rights of all indications of Macrogenis’ PD-1 monoclonal antibody drug MGA012 in October to further strengthen its PD-1 pipeline. It is believed that the combination of MGA012 and Epacadostat will soon begin.
Rova-T is an antibody drug that targets the DLL3 protein on the surface of cancer stem cells. It is used for second-line combined treatment of small cell lung cancer and is still in the experimental stage. AbbVie believes that Rova-T combined with Opdivo or Opdivo + Yervoy will make it a winner in small cell lung cancer, but more clinical trials will be needed to prove its success.
Apalutamide (ARN-509) is a new generation of anti-androgen drugs developed for the treatment of prostate cancer. Johnson & Johnson has been quietly advancing the clinical development of apalutamide, and although these data have not been seen, it is also exciting to see it move towards regulatory agencies. With Johnson & Johnson’s strong business development team, this variety is expected to become a blockbuster drug.
As early as June 2012, Pertuzumab was approved by the FDA. It was used in combination with trastuzumab and docetaxel for metastatic breast cancer without anti-HER2 + therapy or chemotherapy. In September 2013, Pertuzumab was further approved by the FDA. It was used in combination with trastuzumab and chemotherapy for neoadjuvant treatment of HER2 + breast cancer. On December 20, 2017, the FDA approved the combination of Pertuzumab with Trastuzumab and chemotherapy for adjuvant treatment of patients with early-stage HER2 + breast cancer with a higher risk of recurrence. At the same time, the FDA changed Pertuzumab’s previous adjuvant therapy for HER2 + breast cancer from accelerated approval to full approval.
Opdivo is one of the most widely used PD-1 mAbs in clinical practice, and has been approved by the FDA for nine indications. Opdivo’s listing application for second-line treatment of non-small cell lung cancer in China was accepted by the CDE on November 2, 2017, and it was included in the priority review by the CDE on December 18 on the grounds that it has “significant therapeutic advantages compared to existing treatments”.
6) Thiopenfigrastin Injection
Thiofeigrastin injection, 19K (HHPG-19K, polyethylene glycol recombinant human granulocyte stimulating factor injection), can be used clinically for neutropenia associated with chemotherapy in tumor patients. 19K submitted the listing application (CXSS1300007) as early as March 4, 2013. Seeing that it was on the market soon, it caught up with the clinical self-examination on July 22, 2015. On May 18, 2016, Hengrui issued an announcement to withdraw the 19K listing application, and stated that it would complete the relevant research and development data and supplement the application as soon as possible. On March 24, 2017, Hengrui re-applied for the 19K listing under the drug name of thiopefilgrastim injection. It once appeared in CDE with the reason of “obvious treatment advantages compared with existing treatments and major projects”. It is planned to be included in the priority review list. Although it was not included in the final review, the technical review was completed on October 13, 2017, and it is waiting for on-site verification. If successful, it is expected to get CFDA approval in 2018Q2.
Anlotinib is a multi-target tyrosine kinase inhibitor, which can effectively inhibit VEGFR, PDGFR, FGFR, c-Kit and other kinases. It has anti-tumor angiogenesis and inhibits tumor growth. It has obtained major national new drugs Special funding for creation. Anlotinib’s application for the treatment of non-small cell lung cancer was accepted by the CDE on March 16, 2017, and it took a special approval channel. On April 27, 2017, it had “significant treatment advantages compared with existing treatments”. The “major project” reason was included in the priority review by CDE. At present, the technical review of the pharmacology and toxicology and clinical parts has been completed, and the pharmacy part is queued for review. After that, it will enter the on-site inspection and issue a three-in-one report.
Pirlotinib is an EGFR / HER2 small molecule inhibitor, developed for the treatment of HER2 + breast cancer, gastric cancer and NSCLC, and has received special funding from the National Key New Drug Development Program. It is a new drug project that Hengrui has high hopes for. Hengrui submitted to CDE a conditional listing application for pirlotinib for breast cancer. The application was accepted by CDE on August 24, 2017, and it took a special approval channel. On September 26, 2017, it had a “significant clinical value, The “major project” reason was included in the priority review by CDE. At present, the technical review of the clinical part has been completed, and the pharmaceutical and pharmacological and toxicological parts are queued for review. It is expected that the CFDA will be approved in 2018Q2.
Fruquintinib is a small-molecule VEGFR inhibitor independently developed by Hehuang Medicine. It is planned to be developed for the treatment of colorectal cancer, gastric cancer, and NSCLC. Fruquintinib’s application for the treatment of advanced colorectal cancer was accepted by the CDE on June 30, 2017, and it was included in the priority review by the CDE on September 4, 2017 on the grounds that it has “significant clinical value; major projects”. At present, the technical review of the pharmacology and toxicology part has been completed, and the pharmacy and clinical queues are pending review. It is expected to be approved by the CFDA for listing in 2018Q3.
Lynparza is the world’s first PARP inhibitor based on the DNA damage response (DDR) mechanism. It was first approved by the FDA in December 2014 for fourth-line treatment of advanced BRCA + ovarian cancer. On July 17, this year, it was approved by the FDA for second-line maintenance treatment in patients with epithelial ovarian cancer, fallopian tube cancer, and primary peritoneal cancer who relapsed after responding to platinum-based drugs. To date, Lynparza has treated more than 30,000 patients with advanced cancer. On October 18th, AstraZeneca / Mercedon’s Lynparza submitted to the FDA for chemotherapeutic germline BRCA mutation and HER2-metastatic breast cancer marketing application (sNDA) was accepted by the FDA and obtained
priority review qualification, applicable The crowd is expected to expand significantly.
Lemvatinib is a multi-targeted kinase inhibitor that can block a series of regulatory factors including VEGFR1-3, FGFR1-4, PDGFRα, KIT, RET in tumor cells. On February 13, 2015, it was approved by the FDA as a priority review and orphan drug for marketing as a treatment for high-risk differentiated thyroid cancer refractory to radioactive iodine. May 13, 2016 was approved by the FDA in combination with Afinitor to treat advanced renal cell carcinoma with previous anti-VEGF therapy. For liver cancer indications, Eisai submitted a marketing application in Japan in June 2017, submitted a marketing application to the EMA and FDA in July 2017, and submitted a marketing application to the CFDA on November 3, 2017. It was obtained on December 18, 2017 CDE priority review. The FDA granted orphan drug qualification for lenvaltinib to treat hepatocellular carcinoma. It accepted Eisai’s sNDA on September 27, and made an approval decision in accordance with a 10-month standard review process, which will be approved before the end of July.
Ceritinib is a second-generation anaplastic lymphoma kinase (ALK) inhibitor. It was approved by the FDA on April 29, 2014 for crizotinib for intolerance or disease progression in ALK + non-small cell lung cancer, 2017. May 26 FDA approved first-line treatment for ALK + metastatic non-small cell lung cancer. Novartis’ ceritinib capsule listing application was formally accepted by the CDE on December 11, 2017. It should be included in the priority review later (clinical applications have received priority review). It is expected to be approved by the CFDA in 2018Q4. The above summarizes the latest drugs in the treatment of cancer. The drugs are widely used in lung cancer, gastric cancer, liver cancer, breast cancer, and ovarian cancer.