FDA Approves New Treatment Option for Specific Type of Lung Cancer
December 11th, 2015
On December 11, 2015, the FDA granted accelerated approval to Alecensa® (alectinib) for the treatment of people with anaplastic lymphoma kinase (ALK)-positive, metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib.
The indication for Alecensa is approved under accelerated approval based on tumor response rate and duration of response (DOR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
News in brief
- Accelerated approval allows conditional approval of a medicine that fills an unmet medical need for a serious condition based on early evidence suggesting clinical benefit
- Alecensa is Genentech’s third FDA-approved medicine for lung cancer
- Alecensa is being studied for use as an initial (first-line) treatment for people with advanced ALK-positive NSCLC in the Phase III ALEX study, which is part of the company’s commitment to convert the current accelerated approval to a full approval
Important Safety Information
What is the most important information I should know about ALECENSA?
Everyone reacts differently to treatment with ALECENSA. It’s important to know the most serious and most common side effects with ALECENSA.
Your doctor may lower the dose or stop treatment with ALECENSA if any serious side effects occur. Contact your doctor right away if you have any of the following side effects.
ALECENSA may cause serious side effects, including:
Liver problems (hepatotoxicity). ALECENSA may cause liver injury. Your doctor will do blood tests at least every 2 weeks for the first 2 months and as needed during treatment with ALECENSA. Tell your doctor right away if you get any of the following signs and symptoms:
- Feeling tired
- Feeling less hungry than usual
- Yellowing of your skin or the whites of your eyes
- Dark urine
- Itchy skin
- Nausea or vomiting
- Pain on the right side of your stomach area
- Bleeding or bruising more easily than normal
Lung problems. ALECENSA may cause severe or life-threatening swelling (inflammation) of the lungs during treatment. Symptoms may be similar to those symptoms from lung cancer. Tell your doctor right away if you have any new or worsening symptoms, including:
- Trouble breathing
- Shortness of breath
Slow heartbeat (bradycardia). ALECENSA may cause very slow heartbeats that can be severe. Your doctor will check your heart rate and blood pressure during treatment with ALECENSA. Tell your doctor right away if you feel dizzy, lightheaded, or faint during treatment with ALECENSA. Tell your doctor if you take any heart or blood pressure medicines.
Muscle pain, tenderness, and weakness (myalgia). Muscle problems are common with ALECENSA and can be severe. Your doctor will do blood tests at least every 2 weeks for the first month and as needed during treatment with ALECENSA. Tell your doctor right away if you have any new or worsening signs and symptoms of muscle problems, including unexplained muscle pain or muscle pain that does not go away, tenderness, or weakness.
What should I tell my doctor before taking ALECENSA?
Before you take ALECENSA, tell your doctor about all of your medical conditions, including if you:
- Have liver problems
- Have lung or breathing problems
- Have a slow heartbeat
- Are pregnant or plan to become pregnant. ALECENSA can harm your unborn baby. Tell your doctor right away if you become pregnant during treatment with ALECENSA or think you may be pregnant
- Women who are able to become pregnant should use effective birth control during treatment with ALECENSA and for 1 week after the final dose of ALECENSA
- Men who have female partners that are able to become pregnant should use effective birth control during treatment with ALECENSA and for 3 months after the final dose of ALECENSA
- Are breastfeeding or plan to breastfeed. It is not known if ALECENSA passes into your breast milk. Do not breastfeed during treatment with ALECENSA and for 1 week after the final dose of ALECENSA. 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 medicines, over-the-counter medicines, vitamins, and herbal supplements.
What should I avoid while taking ALECENSA?
Avoid spending time in the sunlight during treatment with ALECENSA and for 7 days after the final dose of ALECENSA. You may burn more easily and get severe sunburns. Use sunscreen and lip balm with a SPF 50 or greater to help protect against sunburn.
What are the possible side effects of ALECENSA?
The most common side effects of ALECENSA include:
- Swelling in your hands, feet, ankles, and eyelids
These are not all of the possible side effects of ALECENSA. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects.
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 additional Important Safety Information in full Prescribing Information, including Patient Information.