When 61-year-old Anne Granum beat ovarian cancer for a second time in spring 2017, she and her husband sought a way to find more help.
The answer, she says, came in the form of a once daily pill that has helped delay the progression of her cancer for over a year without undergoing further chemotherapy.
“I’ve been back at work since January, when I didn’t think I’d ever be able to go back to work,” says Granum, who is a Fairfax, Virgina-based mom of five and a marketing executive for a Missouri-based startup. “I am back to living my life — I never thought that would happen.”
A new approach to ovarian cancer treatment
The pill that has helped ward off Granum’s cancer is called niraparib, and it is part of an emerging class of maintenance therapeutics for ovarian cancer.
In the past, maintenance therapy wasn’t successful and posed intolerable side effects, says Dr. Elena Ratner, an associate professor of obstetrics, gynecology and reproductive sciences, and the co-chief in the section of gynecologic oncology at Yale University (Ratner has not treated Granum.) But trials over the past few years suggest that other drugs can be a successful way to slow cancer’s progression, and pose more manageable side effects, says Ron Peck, senior vice president of clinical research at TESARO, the drug company that sells niraparib under the brand name ZEJULA. Some of these side effects may include neutropenia (low white blood cell count), thrombocytopenia (low blood platelet count) and hypertension.
“The benefit is particularly pronounced in patients with a mutation in the BRCA gene, but the benefit has also been seen across all other populations including those without a BRCA gene mutation as well, and its approval is for patients regardless of type,” says Peck. Patients with BRCA1 and BRCA2 gene mutations have a higher risk of ovarian and breast cancer than those patients without them, according to the American Cancer Society.
The Food and Drug Administration fast-tracked approval of niraparib in March 2017 after a large-scale, multi-center study demonstrated that it could promote progression-free survival in patients with recurrent ovarian cancer who had a partial or complete response to platinum-based chemotherapy.
The importance of self-education and advocacy
But because this type of therapy is relatively new and it can take time for new standards of care to develop, many oncologists may not suggest them as an option in recurrent ovarian cancer maintenance treatment, Peck says.
In fact, although the “vast majority” of patients with recurrent ovarian cancer are eligible for maintenance therapy, Ratner says, data from TESARO suggest only 30 to 35 percent of this eligible population received a poly (ADP-ribose) polymerase (PARP) inhibitor, the class of drugs that niraparib falls under.
Yet starting the conversation is crucial, Granum emphasizes. After all, had she not done just that when her initial doctor warned lifelong chemo would be the only option if her cancer recurred again, there’s a chance she wouldn’t be where she is today.
“Get second and third opinions, find out who the best OBGYN oncologists are out there,” says Granum, “and if you don’t like what you’re hearing, go get another opinion.”
Granum is quick to point out that she isn’t sure what the future holds for her health, but with her energy back, plus three grandchildren and another on the way, she is hopeful.
“I thought I was going to die — they had told me that life expectancy was five years,” Granum says. “We don’t know how long this is going to last, but I don’t care. Every single day, I am grateful I get to wake up.”
Indication
ZEJULA is a prescription medicine used for the maintenance treatment of adults with ovarian cancer, fallopian tube cancer, or primary peritoneal cancer, when the cancer comes back. ZEJULA is used after the cancer has responded (complete or partial response) to treatment with platinum-based chemotherapy.
It is not known if ZEJULA is safe and effective in children.
Important Safety Information
ZEJULA may cause serious side effects, including:
Bone marrow problems called Myelodysplastic Syndrome (MDS) or a type of blood cancer called Acute Myeloid Leukemia (AML). Some people who have ovarian cancer and who have received previous treatment with chemotherapy or certain other medicines for their cancer have developed MDS or AML during treatment with ZEJULA. MDS or AML may lead to death.
Symptoms of low blood cell counts (low red blood cells, low white blood cells, and low platelets) are common during treatment with ZEJULA, but they can be a sign of serious bone marrow problems, including MDS or AML. These symptoms may include the following:
- Weakness
- Feeling tired
- Weight loss
- Frequent infections
- Fever
- Shortness of breath
- Blood in urine or stool
- Bruising or bleeding more easily
Your doctor will do blood tests to check your blood cell counts before treatment with ZEJULA. You will be tested weekly for the first month of treatment with ZEJULA, monthly for the next 11 months of treatment, and from time to time afterward.
High blood pressure is common during treatment with ZEJULA, and it can become serious. Your doctor will check your blood pressure and heart rate monthly for the first year during your treatment with ZEJULA and as needed afterward. Your doctor may lower the dose of ZEJULA to treat high blood pressure
Before starting to take ZEJULA, tell your doctor about all of your medical conditions, including if you:
- Have heart problems
- Have high blood pressure
- Are pregnant or plan to become pregnant. ZEJULA may harm an unborn baby and may cause loss of pregnancy (miscarriage)
- If you are able to become pregnant, you should use effective birth control (contraception) during treatment with ZEJULA and for 6 months after taking the last dose of ZEJULA
- If you are able to become pregnant, your doctor may perform a pregnancy test before you start treatment with ZEJULA
- You should tell your doctor right away if you become pregnant
- Are breastfeeding or plan to breastfeed
- ZEJULA may harm your baby. You should not breastfeed your baby during treatment with ZEJULA and for 1 month after taking the last dose of ZEJULA
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements
The most common side effects of ZEJULA include the following:
- Heart not beating regularly
- Nausea
- Constipation
- Vomiting
- Pain in the stomach area
- Mouth sores
- Diarrhea
- Indigestion or heartburn
- Dry mouth
- Tiredness
- Loss of appetite
- Urinary tract infection
- Shortness of breath
- Cough
- Rash
- Changes in liver function blood tests
- Pain in your joints, muscles, and back
- Headache
- Dizziness
- Change in the way food tastes
- Trouble sleeping
- Anxiety
- Sore throat
If you have certain side effects, then your doctor may change your dose of ZEJULA, temporarily stop your treatment with ZEJULA, or permanently stop treatment with ZEJULA.
These are not all the possible side effects of ZEJULA. 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 Prescribing Information
Content created with the help of TESARO