How COPIKTRA May Help with CLL/SLL
FDA approval for COPIKTRA was based on a study of 196 people with CLL or SLL who had at least two prior therapies.
- 95 received COPIKTRA compared with 101 who received ofatumumab
- For those taking COPIKTRA, time without their disease worsening was extended by 7.3 months compared with people who received ofatumumab
COPIKTRA extended progression-free survival by 7.3 months in patients treated for CLL/SLL when compared to ofatumumab.
- Progression-free survival (PFS) is the length of time on treatment that someone lives with cancer but it does not get worse. The study measured PFS with COPIKTRA compared to ofatumumab.
- For those people in the study, the median progression-free survival was 16.4 months for COPIKTRA vs. 9.1 months for ofatumumab. Median means the middle value, so half of the people in the study would fall above the value and half of the people would fall below the value.
- The study measured overall response rate (ORR) in people who had received at least two prior therapies. ORR is a percentage of patients whose cancer shrinks or disappears after treatment.
- A partial response means that fewer signs of the disease were observed in blood tests, x-rays, CT scans, or bone marrow tests in response to the treatment. All responses were partial responses.
What is the most important information about COPIKTRA?
COPIKTRA can cause serious side effects, including:
- Infections. Infections are common during COPIKTRA treatment and can be serious and can lead to death. Tell your healthcare provider right away if you have a fever, chills, or other signs of an infection during treatment with COPIKTRA.
- Diarrhea or inflammation of your intestine. Diarrhea or inflammation of your intestine (colitis) is common during COPIKTRA treatment and can be serious and can lead to death. Your healthcare provider may prescribe an antidiarrhea medicine for your diarrhea. Tell your healthcare provider right away if you have any new or worsening diarrhea, stool with mucus or blood, or if you have severe stomach-area (abdominal) pain. Your healthcare provider should prescribe medicine to help your diarrhea and check you at least weekly. If your diarrhea is severe or anti-diarrhea medicines did not work, you may need treatment with a steroid medicine.
- Skin reactions. Rashes are common with COPIKTRA treatment. COPIKTRA can cause rashes and other skin reactions that can be serious and can lead to death. Tell your healthcare provider right away if you get a new or worsening skin rash, or other skin reactions during treatment with COPIKTRA, including:
- painful sores or ulcers on your skin, lips, or in your mouth
- severe rash with blisters or peeling skin
- rash with itching
- rash with fever
- Inflammation of the lungs. COPIKTRA can cause inflammation of your lungs which can be serious and can lead to death. Tell your healthcare provider right away if you get new or worsening cough or difficulty breathing. Your healthcare provider may do tests to check your lungs if you have breathing problems during treatment with COPIKTRA. Your healthcare provider may treat you with a steroid medicine if you develop inflammation of the lungs that is not due to an infection.
If you have any of the above serious side effects during treatment with COPIKTRA, your healthcare provider may stop your treatment for a period of time, change your dose of COPIKTRA, or completely stop your treatment with COPIKTRA.
COPIKTRA may cause other serious side effects, including:
Elevated liver enzymes. COPIKTRA may cause abnormalities in liver blood tests. Your healthcare provider should do blood tests during your treatment with COPIKTRA to check for liver problems. Tell your healthcare provider right away if you get any symptoms of liver problems, including yellowing of your skin or the white part of your eyes (jaundice), pain in the abdominal region, bruising or bleeding more easily than normal.
Low white blood cell count (neutropenia). Neutropenia is common with COPIKTRA treatment and can sometimes be serious. Your healthcare provider should check your blood counts regularly during treatment with COPIKTRA. Tell your healthcare provider right away if you have a fever or any signs of infection during treatment with COPIKTRA.
Common side effects of COPIKTRA include:
- upper respiratory infection
- bone and muscle pain
- low red blood cell count
These are not all the possible side effects of COPIKTRA. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 and to Secura Bio at 1-844-9SECURA (1-844-973-2872).
Before taking COPIKTRA, tell your healthcare provider about all your medical conditions, including if you:
- have intestinal problems
- have lung or breathing problems
- have an infection
- are pregnant or plan to become pregnant. COPIKTRA can harm your unborn baby.
- Your healthcare provider should do a pregnancy test to see if you are pregnant before you start treatment with COPIKTRA.
- Females who are able to become pregnant should use effective birth control (contraception) during treatment with COPIKTRA and for at least 1 month after the last dose of COPIKTRA. Talk to your healthcare provider about birth control methods that may be right for you. Tell your healthcare provider right away if you become pregnant or think you are pregnant during treatment with COPIKTRA.
- Males with female partners who are able to become pregnant should use effective birth control (contraception) during treatment with COPIKTRA and for at least 1 month after the last dose of COPIKTRA.
- are breastfeeding or plan to breastfeed. It is not known if COPIKTRA passes into breast milk. Do not breastfeed during treatment and for at least 1 month after the last dose of COPIKTRA.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. COPIKTRA and certain other medicines may affect each other.