Multiple Pharmaceutical Companies Receive FDA Approvals for New Treatments in Lung Cancer and Other Indications Since August

　　【Pharmaceutical Network Product InformationSince entering August, several pharmaceutical companies, including Prinpharm, Bluebird Bio, Huahai Pharmaceutical, and AstraZeneca, have announced that their relevant drugs have received approval from the U.S. Food and Drug Administration (FDA).
 

PrPharm announced on the evening of August 21 that it had recently received the approval notice for injectable Daptomycin from the U.S. Food and Drug Administration (FDA). This marks that PrPharm's injectable Daptomycin is qualified for marketing and sales in the United States.
 

Data shows that daptomycin, a cyclic lipopeptide antibiotic discovered by Lilly and developed by Cubist Pharmaceuticals, was approved by the U.S. Food and Drug Administration (FDA) through an expedited review process on September 12, 2003. Marketed under the brand name CUBICIN, it is used to treat complicated skin and skin structure infections and bacteremia caused by Staphylococcus aureus. Currently, injectable daptomycin has been widely marketed globally. After the successful development of its generic version of injectable daptomycin, Prima Biopharm submitted generic drug marketing applications in multiple countries and regions, including the United States, Europe, China, the United Kingdom, and Australia, as part of a shared production line.
 

　Bluebird Bio's Gene Therapy for Rare Blood Disorders Receives FDA Approval in the U.S.
 

News on August 18, the U.S. Food and Drug Administration (FDA) approved Bluebird Bio's Zynteglo gene therapy on Wednesday local time. This one-time therapy is used to treat patients with β-thalassemia who require regular blood transfusions, priced at a record-breaking 2.8 million US dollars.
 

Data shows that Zynteglo is a lentiviral gene therapy based on Bluebird Bio's LentiGlobin platform. It is a one-time treatment that first extracts hematopoietic stem cells from the patient’s bone marrow, then uses a lentivirus to introduce the functional β-globin gene into the patient’s own hematopoietic stem cells, restoring hemoglobin production.
 

　　Huahai Pharmaceutical's Tadalafil Tablets Receive FDA Approval Number
 

On August 15, Huahai Pharmaceutical announced that it had received a notification from the U.S. Food and Drug Administration (FDA) stating that the company's Abbreviated New Drug Application (ANDA, which is the application for generic drugs in the United States, and approval by the U.S. FDA means the applicant can manufacture and sell the product in the U.S. market) for Tadalafil Tablets had been approved.
 

Data shows that Tadalafil Tablets were developed by Eli Lilly and approved by the FDA for marketing in the United States in 2003. Currently, the main manufacturers of Tadalafil Tablets for this indication in the U.S. market include Teva, Lupin, Zydus, etc. In 2021, the sales revenue of Tadalafil Tablets for this indication in the U.S. market was approximately 53.69 million USD.
 

　AstraZeneca's Antibody-Drug Conjugate Enhertu Receives FDA Approval for Non-Small Cell Lung Cancer Treatment
 

On August 12, the U.S. FDA announced the accelerated approval of Enhertu (trastuzumab deruxtecan), an antibody-drug conjugate (ADC) jointly developed by AstraZeneca (AZN.US) and Daiichi Sankyo, for expanded use in treating patients with unresectable or metastatic non-small cell lung cancer (NSCLC) harboring activating HER2 mutations.
 

This is the FDA-approved drug for treating HER2-mutated NSCLC. On August 13, the U.S. FDA also approved the companion diagnostic for Enhertu in this indication, assisting healthcare professionals in identifying patients who could benefit from this new treatment option.
 

　Heavyweight MET Inhibitor Capmatinib for Lung Cancer Approved by US FDA
 

On August 10, Capmatinib (Tabrecta) was approved by the US FDA for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mesenchymal-epithelial transition (MET) exon 14 skipping mutation (MET ex14) [as detected by an FDA-approved test].
 

Data shows that capmatinib is a highly selective MET inhibitor with both in vivo and in vitro activity. Compared with other inhibitors, capmatinib is one of the most effective inhibitors targeting the MET gene. On May 7, 2020, the US FDA granted accelerated approval to the MET inhibitor capmatinib for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) harboring MET exon 14 skipping mutations. On April 24, 2022, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency recommended granting a marketing authorization for capmatinib to treat adult patients with advanced non-small cell lung cancer carrying MET exon 14 skipping mutations.