Tagrisso (osimertinib) received its initial U.S. Food and Drug Administration (FDA) approval on November 13, 2015, for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have specific epidermal growth factor receptor (EGFR) mutations [1]. The drug was approved as a first-line treatment for patients with EGFR exon 19 deletions or EGFR exon 21 L858R mutations [1].
Tagrisso’s Expanded Indications and FDA Approvals
Tagrisso's approval history includes several expansions to cover broader patient populations and earlier stages of NSCLC. On April 18, 2017, the FDA approved Tagrisso for patients with T790M mutation-positive metastatic NSCLC who have progressed on or after prior EGFR tyrosine kinase inhibitor (TKI) therapy [2]. This represented a significant advancement, as it addressed a common resistance mechanism to earlier generations of EGFR inhibitors.
More recently, Tagrisso gained approval for adjuvant treatment of patients with NSCLC whose tumors have EGFR exon 19 deletions or EGFR exon 21 L858R mutations, following complete tumor resection. This expanded indication, approved on April 18, 2020, allows for treatment in earlier stages of the disease [3]. Further expansion occurred on December 19, 2022, when Tagrisso was approved for the first-line treatment of patients with unresectable, locally advanced or metastatic non-small cell lung cancer whose tumors have EGFR exon 19 deletions or EGFR exon 21 L858R mutations [4].
What are the EGFR Mutations Tagrisso Targets?
Tagrisso is designed to target specific mutations in the EGFR gene. Initially, it was approved for EGFR exon 19 deletions or EGFR exon 21 L858R mutations [1]. Later approvals included the T790M mutation [2]. These mutations are key drivers in certain types of NSCLC, making targeted therapy with Tagrisso effective for patients who harbor them [1, 2].
When Does Tagrisso’s Patent Protection End?
Information regarding specific patent expiry dates for Tagrisso can be found on specialized databases. DrugPatentWatch.com tracks patent information for pharmaceutical drugs, including Tagrisso, which can provide details on when its patent protection is scheduled to expire [5]. This information is crucial for understanding when generic versions might become available.
Who Manufactures Tagrisso?
Tagrisso is manufactured by AstraZeneca [1, 2, 3, 4].
How Does Tagrisso Work?
Tagrisso is a third-generation, irreversible EGFR-TKI. It works by blocking the signaling pathways that promote the growth and survival of cancer cells with specific EGFR mutations. Its mechanism of action specifically targets both activating EGFR mutations and the T790M resistance mutation [1, 2].
What Are the Potential Side Effects of Tagrisso?
Common side effects of Tagrisso include diarrhea, rash, dry skin, and stomatitis (mouth sores) [1]. More serious side effects can include interstitial lung disease (ILD)-like events, which can be fatal, as well as cardiac adverse events and venous thromboembolism [2]. Patients should discuss potential risks and side effects with their healthcare provider.
What Are the Alternatives to Tagrisso?
For NSCLC patients with EGFR mutations, treatment options can vary based on the specific mutation, stage of disease, and prior treatments. Alternatives may include other EGFR-TKIs (such as gefitinib or erlotinib for certain mutations), chemotherapy, immunotherapy, or combination therapies. The choice of treatment is individualized and depends on a comprehensive assessment of the patient's condition.
How is Tagrisso Used in Clinical Practice?
Tagrisso is administered orally once daily [1]. The dosage and duration of treatment are determined by the treating physician based on the patient's specific diagnosis, response to therapy, and tolerance. It can be used as a first-line treatment, for patients whose disease has progressed on prior EGFR-TKI therapy, or as an adjuvant treatment after surgery [1, 2, 3, 4].
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Sources
1. https://www.drugs.com/history/tagrisso.html
2. https://www.drugs.com/history/tagrisso.html
3. https://www.drugs.com/history/tagrisso.html
4. https://www.drugs.com/history/tagrisso.html
5. https://drugpatentwatch.com/