First-in-Class Treatment Brings Hope to Patients with Advanced Non-Small-Cell Lung Cancer
Norman Pease was diagnosed in 2012 with non-small cell lung cancer (NSCLC) and progressed beyond treatment with an epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI), and was found to have the T790M mutation. He knew that he was going to be facing one of the biggest challenges of his life. Resolute, he and his wife committed to doing all they could to help him live the life he wanted.
Norman is not alone in his experience, approximately 85 percent of all lung cancers in the US are NSCLC, and about 15% of these are EGFR mutation-positive. Nearly two-thirds of patients with this mutation who are treated with a first-generation EGFR-TKI will form further resistance due to a secondary mutation, T790M.
Norman was treated with what was then an investigational drug known as AZD9291, and is now TAGRISSO™ (osimertinib), which was recently approved by the US Food and Drug Administration (FDA) and is the first targeted therapy for the treatment of patients with metastatic EGFR T790M mutation-positive NSCLC, as detected by an FDA-approved test, who have progressed on or after TKI therapy.
The unmet need amongst these patients was so great that TAGRISSO was granted Breakthrough Therapy designation, Accelerated Approval, Orphan Drug and Fast Track status by the FDA, making it one of the fastest prescription drugs approved within the oncology therapeutic area from first in human to US FDA approval.
“The accelerated regulatory track that led to the approval of TAGRISSO demonstrates the urgent need for patients living with this disease,” said David Fredrickson, Vice President, Specialty Care, AstraZeneca US. “The approval of TAGRISSO is another step forward in ensuring that NSCLC patients receive targeted care for the treatment of their disease.”
With this breakthrough therapy for patients, AstraZeneca continues to make significant progress in delivering a robust pipeline of targeted, innovative oncology treatments. We see a future in which lung cancer becomes a chronic disease that patients can effectively manage.
“I feel like Norman has been very fortunate to receive this kind of targeted care. My hats off to these researchers,” said Sydney Pease, Norman’s wife. “It is just a remarkable thing that they do. We as a couple are grateful.”
Pictured above, Norman Pease with his wife, Sydney Pease.
To learn more about TAGRISSO and hear from other patients like Norman, visit our multimedia news release on this announcement.
Important Safety Information about TAGRISSO
TAGRISSO is a prescription medicine used to treat non-small cell lung cancer (NSCLC). TAGRISSO may be used when your NSCLC has spread to other parts of the body and:
- has a certain type of abnormal epidermal growth factor receptor (EGFR) gene, and
- you have had previous treatment with an EGFR tyrosine kinase inhibitor medicine and it has stopped working
Your doctor will perform a test to make sure that TAGRISSO is right for you.
TAGRISSO may cause serious side effects, including:
- lung problems. TAGRISSO may cause lung problems that may lead to death. Symptoms may be similar to those symptoms from lung cancer. Tell your doctor right away if you have any new or worsening lung problem symptoms, including trouble breathing, shortness of breath, cough, or fever.
- heart problems, including heart failure. TAGRISSO may cause heart problems that may lead to death. Your doctor should check your heart function before you start taking TAGRISSO and during treatment. Call your doctor right away if you have any of the following signs and symptoms of a heart problem: feeling like your heart is pounding or racing, shortness of breath, swelling of your ankles and feet, feeling lightheaded.
Before taking TAGRISSO, tell your doctor if you:
- have lung or breathing problems
- have heart problems, including a condition called long QTc syndrome
- have problems with your electrolytes, such as sodium, potassium, calcium or magnesium
- are pregnant or plan to become pregnant. TAGRISSO can harm an unborn baby. Tell your doctor right away if you become pregnant during TAGRISSO treatment or think you may be pregnant.
- Females who are able to become pregnant should use an effective birth control during TAGRISSO treatment and for 6 weeks after the final TAGRISSO dose.
- Males who have female partners that are able to become pregnant should use effective birth control during TAGRISSO treatment and for 4 months after the final TAGRISSO dose.
- are breastfeeding or plan to breastfeed. It is not known if TAGRISSO passes into your breast milk. Do not breastfeed during TAGRISSO treatment and for 2 weeks after your final TAGRISSO dose. Talk to your doctor about the best way to feed your baby during this time.
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, or herbal supplements. Especially tell your doctor if you take a heart or blood pressure medicine.
The most common side effects of TAGRISSO are:
- dry skin
- changes in your nails, including: redness, tenderness, pain, inflammation, brittleness, separation from nailbed, and shedding of nails
Tell your doctor if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of TAGRISSO. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Please see accompanying complete Prescribing Information including Patient Information.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.fda.gov/medwatch, or call 1-800-FDA-1088.
3160618 Last updated: 11/15