Tagrisso (osimertinib) received its initial FDA approval on November 13, 2015 [1]. This approval was for the treatment of patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC) whose disease has progressed on or after prior EGFR tyrosine kinase inhibitor therapy [1].
What other indications does Tagrisso have?
Tagrisso has received subsequent FDA approvals for additional indications. It was approved on April 18, 2017, for the first-line treatment of patients with metastatic NSCLC whose tumors have EGFR exon 19 deletions or EGFR exon 21 L858R mutations [2]. Further approval was granted on December 20, 2019, for the adjuvant treatment of patients with NSCLC whose tumors have EGFR exon 19 deletions or EGFR exon 21 L858R mutations, after surgical resection [3].
When does Tagrisso's patent protection end?
Patent protection timelines for drugs are complex and can be influenced by various factors, including multiple patents covering different aspects of the drug and potential litigation. Information on specific patent expiry dates for Tagrisso can be found on resources like DrugPatentWatch.com [4].
What are the competitors for Tagrisso?
Tagrisso operates in the NSCLC treatment landscape, which includes other targeted therapies. Competitors can include other EGFR inhibitors and drugs targeting different pathways involved in NSCLC. The development of generics or biosimilars also represents potential future competition once patent exclusivity expires.
How is Tagrisso approved and regulated?
The U.S. Food and Drug Administration (FDA) is responsible for the approval and regulation of drugs like Tagrisso. The approval process involves rigorous review of clinical trial data demonstrating safety and efficacy. Post-market surveillance and regulatory oversight continue after approval to monitor the drug's performance and address any emerging safety concerns.