FDA grants Priority Review to Gilotrif® for uncommon EGFR mutations in advanced NSCLC

RIDGEFIELD, Conn., Oct. 10, 2017 /PRNewswire/ -- Boehringer Ingelheim today announced that the supplemental New Drug Application (sNDA) for Gilotrif® (afatinib) has been accepted for filing and granted Priority Review by the U.S. Food and Drug Administration (FDA). The application for Gilotrif is currently under review for first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 21 (L861Q), G719X or S768I substitution mutations as detected by an FDA-approved test.

Gilotrif is already approved in the U.S., EU (Giotrif®) and many other markets for the first-line treatment of patients with NSCLC whose tumors have EGFR exon 19 deletions or exon 21 (L858R) mutations, and squamous cell carcinoma of the lung whose disease has progressed after treatment with platinum-based chemotherapy.

"The acceptance of the sNDA filing with Priority Review recognizes our company's ongoing commitment to further study Gilotrif in areas of high unmet medical need for patients with few treatment options," said Martina Flammer, M.D., Vice President, Clinical Development & Medical Affairs Specialty Care, Boehringer Ingelheim Pharmaceuticals, Inc. "If approved for this additional indication, Gilotrif would offer the broadest first-line treatment option for patients with EGFR mutation-positive NSCLC."

The submission is based on a meta-analysis of three clinical trials from the LUX-Lung clinical trial program that examined the efficacy of Gilotrif in patients whose tumors have uncommon EGFR mutations. The efficacy outcomes evaluated in the study included: objective response, disease control, duration of response, progression-free survival and overall survival.

Uncommon mutations, which include L861Q, G719X or S7681, represent less than 10 percent of the EGFR mutations found in NSCLC patients and are associated with poor prognosis and survival.

Priority Review designation is granted to applications for drugs that the FDA has determined have the potential to provide significant improvements in the safety or effectiveness of the treatment, diagnosis or prevention of serious conditions compared to available therapies. Under Priority Review, FDA typically takes action within six months of receiving a supplemental application, rather than 10 months, which is the standard review timeframe.

What is Gilotrif?

Gilotrif is a prescription medicine used to treat people with non-small cell lung cancer (NSCLC):

• that has certain types of abnormal epidermal growth factor receptor (EGFR) genes. Your doctor will perform a test to check for certain types of abnormal EGFR genes, and make sure that Gilotrif is right for you. Gilotrif may be used when you have not had previous treatment for cancer that has spread to other parts of the body. It is not known if Gilotrif is safe and effective in treating lung cancer with other abnormal EGFR genes.

or

• that is squamous type and has spread to other parts of the body after you have tried chemotherapy that contains platinum.

It is not known if Gilotrif is safe and effective in children.

IMPORTANT SAFETY INFORMATION ABOUT Gilotrif

Before you take Gilotrif, tell your doctor if you:

• have kidney or liver problems
• have lung or breathing problems other than lung cancer
• have a history of severe dry eye or any other eye problems. Tell your doctor if you wear contact lenses.
• have heart problems
• have any other medical conditions
• are pregnant or plan to become pregnant. Gilotrif can harm your unborn baby. You should not become pregnant while taking Gilotrif.
• Women who are able to become pregnant should use effective birth control during treatment with Gilotrif and for at least 2 weeks after your last dose of Gilotrif. Talk to your doctor about birth control methods that may be right for you.
• Tell your doctor right away if you become pregnant or think you are pregnant while taking Gilotrif.
• are breastfeeding or plan to breastfeed. It is not known if Gilotrif passes into your breast milk. Do not breastfeed while taking Gilotrif and for 2 weeks after your last dose of Gilotrif. Talk to your doctor about the best way to feed your baby if you take Gilotrif.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Gilotrif may affect the way other medicines work, and other medicines may affect the way Gilotrif works.

What to avoid while taking Gilotrif

Limit your time in the sun. Gilotrif can make your skin sensitive to the sun. You could get or have worsening rash or acne. You could get a severe sunburn. Use sunscreen and wear a hat and clothes that cover your skin while you are taking Gilotrif if you have to be in sunlight.

Gilotrif may cause serious side effects, including:

• Diarrhea. Diarrhea is common with Gilotrif and may sometimes be severe. Severe diarrhea can cause loss of body fluid (dehydration) and kidney problems that can sometimes lead to death. During your treatment with Gilotrif, your doctor should prescribe medicines to treat diarrhea. Take this medicine exactly as your doctor tells you to. Tell your doctor if you have diarrhea. Get medical attention right away if your diarrhea does not go away or becomes severe.
• Skin reactions. Gilotrif can cause redness, rash, and acne. It is important to get treatment for skin reactions as soon as you notice them. Take medicines to help skin reactions exactly as your doctor tells you to. Get medical attention right away if you develop severe skin reactions such as peeling or blistering of the skin, or blisters in your mouth.
• Lung or breathing problems. Gilotrif may cause inflammation of the lung 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 problems, or any combination of the following symptoms: trouble breathing or shortness of breath, cough, or fever.
• Liver problems. Gilotrif can cause liver problems that can sometimes lead to death. Tell your doctor right away if you have any symptoms of a liver problem which may include:
• yellowing of your skin or the white part of your eyes (jaundice)
• dark or brown (tea-colored) urine
• pain on the upper right side of your stomach area (abdomen)
• bleeding or bruising more easily than normal
• feeling very tired

Your doctor will do blood tests to check your liver function during your treatment with Gilotrif.

• Eye problems. Tell your doctor right away if you have symptoms of eye problems. Symptoms may include:
• eye pain, swelling, redness, or tearing
• blurred vision
• sensitivity to light
• other changes in your vision
• Heart problems. Tell your doctor right away if you have any symptoms of a heart problem which may include:
• new or worsening shortness of breath while at rest or with activity
• cough
• tiredness
• swelling of your ankles, feet, or legs
• feeling that your heart is pounding or racing (palpitations)
• sudden weight gain

The most common side effects of Gilotrif include diarrhea, rash, mouth sores, nail inflammation, dry skin, acne, decreased appetite, nausea, vomiting, itching.

Gilotrif may cause decreased fertility in females and males. Talk to your doctor if you have concerns about your fertility.

Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all of the possible side effects of Gilotrif. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/safety/medwatch or call 1-800-FDA-1088.

Please see the full Prescribing Information, including Patient Information.

GF CONS ISI APRIL 2016

About Boehringer Ingelheim in Oncology
Boehringer Ingelheim's oncology research is driven by a passion to advance clinical practice and a determination to improve the lives of patients who are battling cancer. Through our own scientific innovation and partnerships, we are focused on discovering and providing novel best-in-class, breakthrough cancer medications that fit the needs of patients, caregivers and healthcare professionals. We have a clear strategy to become a leader in the field of lung cancer. Boehringer Ingelheim has successfully launched two products globally for NSCLC that have been widely adopted and established as valuable additions to current clinical practice. Continuous insights and learnings from research and development are key parts of innovation and our way forward to advance clinical practice in lung cancer and other cancer types.

About Boehringer Ingelheim Pharmaceuticals, Inc.
Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation.

Boehringer Ingelheim is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, the company operates globally with 145 affiliates and about 50,000 employees. Since its founding in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel treatments for human and veterinary medicine.

Boehringer Ingelheim is committed to improving lives and providing valuable services and support to patients and their families. Our employees create and engage in programs that strengthen our communities. To learn more about how we make more health for more people, visit our Corporate Social Responsibility Report.

In 2016, Boehringer Ingelheim achieved net sales of about $17.6 billion (15.9 billion euros). R&D expenditure corresponds to 19.6 percent of its net sales.

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