Tagrisso® (osimertinib) Approved As Adjuvant Therapy for NSCLC

The U.S. Food and Drug Administration (FDA) has granted a new indication (use) for Tagrisso® (osimertinib). The latest indication is for adjuvant therapy after tumor resection (removal) in people with non-small cell lung cancer (NSCLC) with EGFR exon 19 deletions or exon 21 L858R mutations. This is the first adjuvant treatment approved by the FDA for this population.1

Tagrisso received a priority review from the FDA for the new indication. A priority review helps drugs (or new uses for existing drugs) get approved faster than usual so they can help people who need them.1

Tagrisso was already approved for:2

  • First-line treatment of people with metastatic NSCLC whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations
  • Treatment of people with EGFR T790M mutation-positive NSCLC with disease progression on or following EGFR TKI (tyrosine kinase inhibitor) therapy

The approval of Tagrisso allows people with NSCLC with EGFR exon 19 deletions or exon 21 L858R mutations to receive target therapy in an earlier and potentially more curative stage of cancer.1

How does Tagrisso work?

The EGFR (epidermal growth factor receptor) is a protein that is found on the surface of both normal and cancer cells. In people with NSCLC, certain damage to the genes that make EGFR causes cancer cells to grow and spread in the body.1

Tagrisso is classified as a kinase inhibitor drug. These types of drugs bind, or stick, to the gene mutations. This blocks the EGFR protein, which can slow or stop the growth and spread of cancer.1

Evidence for Tagrisso

Tagrisso was approved for the new indication based on the results of a Phase 3 clinical trial. The trial studied 682 people with early-stage NSCLC and EGFR exon 19 deletions or exon 21 L858R mutations. The people in the study also had undergone surgery to remove their tumor.1

The main outcome was disease-free survival (DFS). Results showed that people who took Tagrisso:1,3

  • Had 89 percent DFS after 2 years, compared to 53 percent of people who took the placebo (inactive drug)
  • Had a 79 percent less risk of disease recurrence or death compared to people who took the placebo

Because of these results, an independent data monitoring committee recommended stopping the study early to speed up the review process.1

What are the possible side effects of Tagrisso?

The most common side effects of Tagrisso include:2

  • Diarrhea
  • Low white blood cells, low platelets
  • Rash, dry skin
  • Nail toxicity
  • Swelling and sores in the mouth
  • Fatigue
  • Appetite loss

Other side effects may include:2

  • Nausea and vomiting
  • Constipation
  • Itching
  • Cough
  • Shortness of breath
  • Headache

These are not all the possible side effects of Tagrisso. Talk to your doctor about what to expect or if you experience any changes that concern you during treatment with Tagrisso.

Things to know about Tagrisso

Tagrisso can cause serious, life-threatening hypersensitivity reactions. Seek emergency medical care if you develop skin lesions or severe skin blistering or peeling.2

Tagrisso may cause lung damage or inflammation. Tell your doctor if you experience respiratory symptoms like shortness of breath, cough, or fever.2

Tagrisso may cause heart problems. Tell your doctor if you have cardiac risk factors and/or a history of QT prolongation. Your doctor may monitor your heart function before and during treatment with Tagrisso.2

Tagrisso may cause corneal inflammation. If you take Tagrisso and notice any changes in vision or have any eye pain, inflammation, or redness, see an ophthalmologist as soon as possible.2

Tagrisso may be harmful to a developing baby or may affect fertility:2

  • Women of childbearing age should use effective birth control while taking Tagrisso and for 6 weeks after the last dose
  • Men who take Tagrisso and have a woman partner of childbearing age should use effective birth control while taking Tagrisso and for 4 months after the last dose
  • Women should not breastfeed while taking Tagrisso and for 2 weeks after the last dose

Talk to your doctor to see if Tagrisso is right for you. Tell your doctor about all of the medical conditions you have, and do not change medicines without talking to your doctor first.

Before beginning treatment for lung cancer, tell your doctor about any other drugs, vitamins, or supplements you are taking. This includes over-the-counter drugs.

For more information, read the full prescribing information of Tagrisso.

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