FDA Approves First Personalized Medicine for EGFR Mutation-Positive Metastatic Non-Small Cell Lung Cancer in the United States

May 14th, 2013

On May 14, 2013, the FDA approved Tarceva® (erlotinib) tablets for the initial (first-line) treatment of people with metastatic non-small cell lung cancer (NSCLC) whose tumors have been identified to have certain epidermal growth factor receptor (EGFR) mutations by an FDA-approved test.

The FDA also approved the cobas® EGFR Mutation Test, which was developed by Roche and validated in the pivotal EURTAC study.

News in brief

• Personalized option for initial treatment that helped metastatic NSCLC patients who tested positive for a specific EGFR mutation live longer without their disease worsening (median progression-free survival 10.4 months vs. 5.2 months in a Phase III study).
• Ten to 30 percent of people worldwide with lung cancer have tumors that test positive for certain EGFR mutations.
• Tarceva is already approved for people with advanced-stage NSCLC whose cancer has not spread or grown after initial treatment with certain types of chemotherapy (Maintenance treatment). Tarceva is also approved for people with advanced-stage NSCLC whose cancer has spread or grown after receiving at least one chemotherapy regimen (Second/Third-line treatment).

Indications

• Tarceva is prescribed for patients with metastatic non-small cell lung cancer (NSCLC) whose cancer has been identified to have certain Epidermal Growth Factor Receptor (EGFR) mutations by an FDA-approved test (first-line treatment).
• Tarceva is prescribed for patients with advanced-stage NSCLC whose cancer has not spread or grown after initial treatment with certain types of chemotherapy (maintenance treatment).
• Tarceva is prescribed for patients with advanced-stage NSCLC whose cancer has spread or grown after receiving at least one chemotherapy regimen (second-/third-line treatment).
• Tarceva is not meant to be used at the same time as certain types of chemotherapy for advanced NSCLC.
• Safety and efficacy of Tarceva have not been evaluated as first-line treatment in patients with metastatic NSCLC whose cancer have EGFR mutations other than exon 19 deletions or exon 21 (L858R).

Supporting Information

Important Safety Information

Contact your HCP right away if you experience any of the side effects listed below.

What are the possible side effects of Tarceva?

Tarceva can cause serious side effects, including:

• Lung problems (called interstitial lung disease [ILD] events). Tarceva has been shown to cause lung problems, including death. Symptoms of lung problems may include shortness of breath, cough, and fever. Tarceva may need to be stopped if you have any of these symptoms.
• Liver and kidney problems. Tarceva has been shown to cause severe kidney and liver problems, including death. Some people had their kidneys and liver stop working. Let your HCP know if you have a history of liver or kidney disease.
• Stomach and intestinal problems (called gastrointestinal [GI] perforation). Tarceva has been shown to cause GI perforation, which has led to death. A GI perforation is a hole that develops in your stomach or intestine. Tarceva patients may be at a higher risk for GI perforation if they:
  • Are taking medicines including those that may help block the growth of blood vessels; steroids; non-steroidal anti-inflammatory drugs (NSAIDs); and certain chemotherapies. Always tell your HCP about any medicines you are taking.
  • Have a history of ulcers or other stomach disease.
• Serious skin conditions. Tarceva has been shown to cause blistering and skin peeling. This may result in other serious skin disorders or death.
• Blood, bleeding, and clotting problems. Tarceva has been shown to cause certain blood problems and other bleeding and clotting problems. These have led to stroke and death.
• Eye disorders. Tarceva has been shown to cause dry eyes, unusual eyelash growth, or swelling of the cornea. The cornea is the clear coating of the eyeball. This swelling may irritate or damage the eye.
• Bleeding events when taking warfarin with Tarceva. Tell your HCP if you are taking a blood thinner, such as warfarin. Taking Tarceva with this medicine can cause death.
• Pregnancy. Tarceva can harm an unborn baby. Women should use effective birth control during treatment and for at least 1 month after the last dose of Tarceva. Tell your HCP if you have become pregnant, or if you think you may be pregnant, during treatment with Tarceva. Do not breast-feed during treatment with Tarceva and for 2 weeks after the final dose.

When should I call my HCP while taking Tarceva?

Call your HCP if you have:

• Serious or ongoing diarrhea, nausea (feeling sick to your stomach), loss of appetite, or vomiting.
• New or worsening shortness of breath or cough.
• Eye irritation.
• New or worsening rash, blistering, or peeling of the skin.
• Any changes in smoking habits.

What are some of the most common side effects of Tarceva?

• In 1st-line NSCLC treatment: Diarrhea, weakness, rash, cough, shortness of breath, loss of appetite (not wanting to eat).
• In maintenance/2^nd- or 3^rd-line NSCLC treatment: Rash and diarrhea.
• In pancreatic cancer treatment: Fatigue (feeling very tired), rash, nausea, loss of appetite, diarrhea.

What should I know about skin (including rash), hair, and nail problems or diarrhea while taking Tarceva?

• Skin (including rash):
  • While taking Tarceva, rash could happen or get worse if the skin is exposed to the sun. You may want to use alcohol-free lotions and sunscreens or avoid being out in the sun.
  • Your skin and nails may get darker. You may also have dry skin that may or may not crack. This most often happens with rash.
  • Talk with your HCP if you notice a rash. He or she may be able to help you manage it.
• Hair and nails: Hair and nail problems have been seen in patients taking Tarceva. These include increased hairiness and brittle or loose nails.
• Diarrhea: Diarrhea can usually be treated with anti-diarrhea medicine. Your HCP can help you find the right medicine for you.

What should I do if I am taking or am prescribed other medicines or supplements while taking Tarceva?

• Always tell your HCP about all of the medicines and herbal supplements you are taking.
• DO NOT start taking any new medicines or herbal supplements before talking with your HCP.
• DO NOT eat grapefruit or drink grapefruit juice before talking with your HCP.

Will smoking affect my treatment with Tarceva?

• If you smoke, you should stop smoking before you start treatment with Tarceva.
• If you continue to smoke, your treatment with Tarceva may need to be adjusted. Talk with your HCP if you continue to smoke.

Always talk with your HCP about any side effects you may have with Tarceva.

You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555.

Please see the Tarceva full Product Information for additional Important Safety Information.