Two New Drug Approvals Offer Hope for Ovarian Cancer
- Two PARP inhibitors were recently given new FDA approvals in what’s called first-line maintenance therapy for women with ovarian cancer
- Niraparib (Zejula) has been approved for women of all genetic makeups
- Olaparib (Lynparza) has been approved in combination with a drug called bevacizumab for women who have HRD-positive tumors
- Women need to evaluate the potential benefits vs. side effects
The Food and Drug Administration (FDA) has recently given two PARP inhibitors — olaparib (Lynparza) and niraparib (Zejula) — new approvals that both provide encouraging new options for more women with ovarian cancer.
Niraparib, already approved at recurrence for women regardless of BRCA mutation status, has been approved for frontline maintenance therapy after a full or partial response to chemotherapy, while olaparib has now been approved in combination with a drug called bevacizumab as frontline maintenance for any women who test positive for something called Homologous Recombination Deficiency (HRD) — not necessarily just those with a BRCA mutation.
Maintenance therapy is administered after initial treatment for ovarian cancer with the goal of preventing, or putting off, recurrence. The fact that both drugs have been approved as first-line maintenance treatment for women without a BRCA mutation in recent weeks is really big news in the ovarian cancer field — and comes with a lot of promise.
RELATED: What Are the Side Effects of PARP Inhibitors?
“This is a much anticipated change in the upfront treatment of patients with advanced ovarian cancer,” Dr. Amanika Kumar, a gynecologic oncologist at Mayo Clinic, told SurvivorNet about the approval of niraparib. “Giving patients an option for front-line maintenance that may delay recurrence and improve survival from their cancer is exciting.”
Both niraparib and olaparib are part of a relatively new class of drugs called PARP inhibitors, which block the ability of cancer cells to repair damaged DNA — essentially, causing the cancer cells to die off. The new approvals both state that the drugs can be used as a first-line maintenance treatment for women with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who have responded to first-line platinum-based chemotherapy. However, the way the drugs can be used is different.
Powerful Potential Impact
For this new front-line approval, olaparib was used in combination with bevacizumab, which is a monoclonal antibody that helps prevent the growth of cancer by stopping blood flow to malignant cells, and a woman’s genetic makeup plays more of a role in whether she will be eligible for this treatment option.
The new olaparib approval comes after a phase III clinical trial called PAOLA-1 showed the drug combination reduced the risk of disease progression by 67%. The addition of the PARP inhibitor to treating women with just bevacizumab improved something called progression free survival (PFS) to a median of 37.2 months, meaning relapse could be put off for more than three years.
The recent niraparib approval came after results from a trial called PRIMA showed a significant improvement in PFS for women who were given the PARP inhibitor after responding to first-line platinum-based chemotherapy. The median PFS for women taking niaparib in the study was 21.9 months, compared to 10.4 months for women given a placebo.
Both of these approvals are a really big deal, considering 70-80% of women experience a recurrence within 5 years of ovarian cancer going into remission.
With the two approvals, there are really promising options for women who have ovarian cancer. However, not all women who are treated for the disease will be encouraged to go on a PARP inhibitor. There are risks and benefits to consider, and to discuss with your oncologist.
Assessing Risk Benefit To Make A Personal Treatment Decision
“As with all cancer-related treatment, it will be important to incorporate counseling about the risks and benefits of PARP inhibitor maintenance, and help patients understand their individual likelihood of benefit given their germline genetic and tumor characteristics. Helping educate our patients about the complexity of the tumor-directed treatment options will allow patients and their families to make the best health-related decisions for their lives and circumstances,” Dr. Kumar said.
The most common side effects observed among women who were treated with the olaparib/bevacizumab combination were nausea, fatigue and anemia, according to the FDA’s announcement. For niraparib, common side effects were thrombocytopenia (low blood platelet count), anemia, nausea and fatigue.
Learn more about SurvivorNet's rigorous medical review process.
Two New Drug Approvals Offer Hope for Ovarian Cancer
- Two PARP inhibitors were recently given new FDA approvals in what’s called first-line maintenance therapy for women with ovarian cancer
- Niraparib (Zejula) has been approved for women of all genetic makeups
- Olaparib (Lynparza) has been approved in combination with a drug called bevacizumab for women who have HRD-positive tumors
- Women need to evaluate the potential benefits vs. side effects
The Food and Drug Administration (FDA) has recently given two PARP inhibitors —
olaparib (Lynparza) and
niraparib (Zejula) — new approvals that both provide encouraging new options for more women with ovarian cancer.
Niraparib, already approved at recurrence for women regardless of BRCA mutation status, has been approved for frontline maintenance therapy after a full or partial response to chemotherapy, while olaparib has now been approved in combination with a drug called bevacizumab as frontline maintenance for any women who test positive for something called Homologous Recombination Deficiency (HRD) — not necessarily just those with a BRCA mutation.
Read More
Maintenance therapy is administered after initial treatment for ovarian cancer with the goal of preventing, or putting off, recurrence. The fact that both drugs have been approved as first-line maintenance treatment for women without a BRCA mutation in recent weeks is really big news in the ovarian cancer field — and comes with a lot of promise.
RELATED: What Are the Side Effects of PARP Inhibitors?
“This is a much anticipated change in the upfront treatment of patients with advanced ovarian cancer,” Dr. Amanika Kumar, a gynecologic oncologist at Mayo Clinic, told SurvivorNet about the approval of niraparib. “Giving patients an option for front-line maintenance that may delay recurrence and improve survival from their cancer is exciting.”
Both niraparib and olaparib are part of a relatively new class of drugs called PARP inhibitors, which block the ability of cancer cells to repair damaged DNA — essentially, causing the cancer cells to die off. The new approvals both state that the drugs can be used as a first-line maintenance treatment for women with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who have responded to first-line platinum-based chemotherapy. However, the way the drugs can be used is different.
Powerful Potential Impact
For this new front-line approval, olaparib was used in combination with bevacizumab, which is a monoclonal antibody that helps prevent the growth of cancer by stopping blood flow to malignant cells, and a woman’s genetic makeup plays more of a role in whether she will be eligible for this treatment option.
The new olaparib approval comes after a phase III clinical trial called PAOLA-1 showed the drug combination reduced the risk of disease progression by 67%. The addition of the PARP inhibitor to treating women with just bevacizumab improved something called progression free survival (PFS) to a median of 37.2 months, meaning relapse could be put off for more than three years.
The recent niraparib approval came after results from a trial called PRIMA showed a significant improvement in PFS for women who were given the PARP inhibitor after responding to first-line platinum-based chemotherapy. The median PFS for women taking niaparib in the study was 21.9 months, compared to 10.4 months for women given a placebo.
Both of these approvals are a really big deal, considering 70-80% of women experience a recurrence within 5 years of ovarian cancer going into remission.
With the two approvals, there are really promising options for women who have ovarian cancer. However, not all women who are treated for the disease will be encouraged to go on a PARP inhibitor. There are risks and benefits to consider, and to discuss with your oncologist.
Assessing Risk Benefit To Make A Personal Treatment Decision
“As with all cancer-related treatment, it will be important to incorporate counseling about the risks and benefits of PARP inhibitor maintenance, and help patients understand their individual likelihood of benefit given their germline genetic and tumor characteristics. Helping educate our patients about the complexity of the tumor-directed treatment options will allow patients and their families to make the best health-related decisions for their lives and circumstances,” Dr. Kumar said.
The most common side effects observed among women who were treated with the olaparib/bevacizumab combination were nausea, fatigue and anemia, according to the FDA’s announcement. For niraparib, common side effects were thrombocytopenia (low blood platelet count), anemia, nausea and fatigue.
Learn more about SurvivorNet's rigorous medical review process.
