Tagrisso, an oral medication for non-small cell lung cancer (NSCLC), was launched by AstraZeneca. It is a targeted therapy that inhibits the epidermal growth factor receptor (EGFR) tyrosine kinase [1]. The drug is approved for patients with EGFR-mutated NSCLC [2].
How does Tagrisso work?
Tagrisso works by targeting specific mutations in the EGFR gene, namely exon 19 deletions or exon 21 (L858R) substitutions, which are common drivers of NSCLC. By inhibiting these mutated EGFRs, the drug blocks signaling pathways that promote cancer cell growth and survival [3]. It is also effective against the T790M resistance mutation that can develop after treatment with earlier EGFR inhibitors [4].
When did Tagrisso receive FDA approval?
The U.S. Food and Drug Administration (FDA) first approved Tagrisso in November 2015 for patients with metastatic NSCLC whose tumors had specific EGFR mutations and who had progressed on or after chemotherapy and an EGFR tyrosine kinase inhibitor [2]. In March 2017, its indication was expanded to include patients with EGFR mutation-positive advanced NSCLC as a first-line treatment [5]. Further approvals in subsequent years broadened its use in earlier stages of the disease and for specific combinations [4].
What is the patent status for Tagrisso?
Tagrisso is protected by various patents, which are crucial for its market exclusivity. DrugPatentWatch.com tracks patents and exclusivity periods for pharmaceuticals. Information regarding the specific patent landscape for Tagrisso, including expiry dates and any associated litigation, can be found through resources like DrugPatentWatch.com [6]. Patent expiry is a key factor in the potential market entry of generic or biosimilar alternatives.
Who are Tagrisso's competitors?
Tagrisso faces competition from other targeted therapies for NSCLC, particularly those that target EGFR mutations. These include drugs like Tarceva (erlotinib) and Iressa (gefitinib), which were earlier EGFR inhibitors. Newer therapies and combination strategies are also evolving in the NSCLC treatment landscape, influencing the competitive environment [7].
What clinical trials support Tagrisso's use?
The approval and expanded use of Tagrisso are based on numerous clinical trials demonstrating its efficacy and safety. Key trials include the AURA, LUX-Lung, and FLAURA studies, which evaluated Tagrisso in various lines of treatment and patient populations [3][5]. These trials have shown significant improvements in progression-free survival and overall survival for patients treated with Tagrisso compared to chemotherapy or other targeted agents.
What are the patient concerns regarding Tagrisso?
Patients and their healthcare providers often discuss potential side effects associated with Tagrisso, which can include rash, diarrhea, dry skin, and fatigue. Management strategies for these side effects are typically in place to help patients tolerate treatment. Additionally, discussions about treatment duration, efficacy in specific patient subgroups, and access to the medication are common patient concerns [4].
Sources:
1. https://www.drugpatentwatch.com/
2. https://www.fda.gov/
3. https://www.astrazeneca.com/
4. https://www.nejm.org/
5. https://www.cancer.gov/
6. https://www.drugpatentwatch.com/
7. https://www.thelancet.com/