Table of Contents

• Introduction
• What is Osimertinib?
• How Osimertinib Works
• Clinical Trials and Research
• Dosage and Administration
• Side Effects and Safety
• Frequently Asked Questions
• Glossary

Introduction

Osimertinib, also known by its brand name Tagrisso or research code AZD9291, is a medication used to treat certain types of non-small cell lung cancer (NSCLC). This article will provide an overview of Osimertinib, its uses, how it works, and what patients can expect when taking this medication.^[1][2]

What is Osimertinib?

Osimertinib is a targeted therapy drug used to treat advanced or metastatic non-small cell lung cancer. It is specifically designed for patients whose cancer has certain genetic mutations in the epidermal growth factor receptor (EGFR) gene. These mutations make the cancer cells grow and divide more quickly than normal cells.^[2]

How Osimertinib Works

Osimertinib belongs to a class of drugs called tyrosine kinase inhibitors (TKIs). It works by blocking the activity of the mutated EGFR protein in cancer cells. By doing so, it helps to slow down or stop the growth of cancer cells. This targeted approach means that Osimertinib is more likely to affect cancer cells while causing less damage to healthy cells compared to traditional chemotherapy.^[2]

Clinical Trials and Research

Several clinical trials have been conducted to study the effectiveness and safety of Osimertinib. Some key findings from these trials include:

• Neoadjuvant therapy: One study investigated the use of Osimertinib before surgery (neoadjuvant therapy) in patients with stage IIIA/B NSCLC. Patients received 80 mg of Osimertinib daily for 6 or 12 weeks, depending on their response to treatment.^[1]
• First-line treatment: Another study looked at Osimertinib as a first-line treatment for advanced EGFR mutation-positive NSCLC. This trial aimed to evaluate the mechanisms of resistance to Osimertinib and its efficacy and safety.^[2]
• Bioavailability studies: Researchers have also conducted studies to determine how different formulations of Osimertinib (capsules, tablets, and solutions) are absorbed by the body and how food affects its absorption.^[3]

Dosage and Administration

Based on the clinical trials, Osimertinib is typically administered as follows:

• The standard dose is 80 mg taken orally once daily.
• It can be given as a tablet or capsule.
• Treatment duration varies depending on the patient’s response and the specific use (e.g., before surgery or as ongoing treatment).
• Some studies have investigated the effects of taking Osimertinib with or without food.^[1][2][3]

Side Effects and Safety

As with any medication, Osimertinib can cause side effects. Clinical trials have monitored patients for various safety concerns, including:

• Adverse events
• Changes in vital signs
• Abnormalities in ECG readings
• Changes in laboratory test results
• Effects on eye health

It’s important for patients to discuss potential side effects with their healthcare provider and report any unusual symptoms during treatment.^[3]

Frequently Asked Questions

1. Who is Osimertinib suitable for?

Osimertinib is primarily used for patients with non-small cell lung cancer who have specific mutations in the EGFR gene. Your doctor will perform genetic testing to determine if you are eligible for this treatment.

2. How long do patients typically take Osimertinib?

The duration of treatment can vary depending on the individual case and how the cancer responds. In some studies, patients received the drug for 6 to 12 weeks before surgery, while in others, treatment continued until the disease progressed.

3. Can Osimertinib be taken with food?

Some studies have investigated the effects of taking Osimertinib with and without food. It’s best to follow your doctor’s specific instructions regarding when and how to take the medication.

Summary Table

Glossary

• Epidermal Growth Factor Receptor (EGFR) – A protein on the surface of cells that helps them grow and divide. Some NSCLC cells have mutations in the gene for EGFR, making them grow faster.
• Tyrosine Kinase Inhibitor (TKI) – A type of drug that blocks specific enzymes called tyrosine kinases, which are involved in cell growth and division.
• Neoadjuvant Therapy – Treatment given before the main treatment, usually before surgery, to shrink the tumor.
• Bioavailability – The proportion of a drug that enters the circulation when introduced into the body and is able to have an active effect.

Trial Sources

• [1]: https://clinicaltrials.gov/study/NCT02824952
• [2]: https://clinicaltrials.gov/study/NCT03969823
• [3]: https://clinicaltrials.gov/study/NCT01951599