US Food and Drug Administration (FDA) approves a new indication for LYNPARZA® (olaparib)
On May 28th, 2020
US Food and Drug Administration (FDA) approved a new indication for LYNPARZA® (olaparib), as a treatment option for adult patients with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC) who have progressed following prior treatment with enzalutamide or abiraterone. Patients will be selected for therapy based on an FDA-approved companion diagnostic for LYNPARZA.1
The approval was based on results from the Phase III PROfound trial, published in the New England Journal of Medicine, which showed LYNPARZA reduced the risk of disease progression or death by 66% (equal to a hazard ratio of 0.34 and p-value of <0.0001) and improved radiographic progression-free survival (rPFS) to a median of 7.4 versus 3.6 months with enzalutamide or abiraterone in men with BRCA1/2 or ATM gene-mutated mCRPC.1 Additionally, results showed:
- A statistically significant improvement in the select secondary endpoint of overall survival (OS) in men with BRCA1/2 or ATM gene-mutated mCRPC. LYNPARZA reduced the risk of death by 31% (equal to a hazard ratio of 0.69 and p-value 0.0175) and improved OS to a median of 19.1 months versus 14.7 months for those treated with enzalutamide or abiraterone.1
- A statistically significant improvement in objective response rate of 33% in men with BRCA1/2 or ATM gene-mutated mCRPC treated with LYNPARZA vs 2% treated with enzalutamide or abiraterone (p-value of <0.0001).1
- In men with HRR-mutated mCRPC, LYNPARZA reduced the risk of disease progression or death by 51% (equal to a hazard ratio of 0.49 and p-value of <0.0001) and improved rPFS to a median of 5.8 months versus 3.5 months with abiraterone or enzalutamide.1
Fatal adverse reactions occurred in 4% of patients treated with LYNPARZA. These included pneumonia (1.2%), cardiopulmonary failure (0.4%), aspiration pneumonia (0.4%), intestinal diverticulum (0.4%), septic shock (0.4%), Budd-Chiari Syndrome (0.4%), sudden death (0.4%), and acute cardiac failure (0.4%).1 Serious adverse reactions occurred in 36% of patients receiving LYNPARZA. Serious adverse reactions in ≥2% were anemia (9%), pneumonia (4%), pulmonary embolism (2%), fatigue/asthenia (2%), and urinary tract infection (2%).1
The most common adverse reactions (Grade 1-4) occurring in ≥10% in the LYNPARZA arm (N=256) were anemia (46%), nausea (41%), fatigue including asthenia (41%), decreased appetite (30%), diarrhea (21%), vomiting (18%), thrombocytopenia (12%), cough (11%) and dyspnea (10%).1
In addition, venous thromboembolic events, including pulmonary embolism, occurred in 7% of patients with metastatic castration-resistant prostate cancer who received LYNPARZA plus androgen deprivation therapy (ADT) compared to 3.1% of patients receiving enzalutamide or abiraterone plus ADT in the PROfound study. Patients receiving LYNPARZA and ADT had a 6% incidence of pulmonary embolism compared to 0.8% of patients treated with ADT plus either enzalutamide or abiraterone.1
This is the seventh indication approved for LYNPARZA in the US, making it the first targeted therapy in men with metastatic castration-resistant prostate cancer with HRR gene mutations to be approved by the FDA based on a Phase III trial. LYNPARZA is associated with serious, potentially fatal risks, including myelodysplastic syndrome/acute myeloid leukemia (MDS/AML), pneumonitis and venous thromboembolic events. LYNPARZA can also cause fetal harm. Please see additional Important Safety Information below.
Included in this email is a LYNPARZA sample treatment plan template for the new indication in prostate cancer. This is an example of an Electronic Health Record (EHR) order set.
As a reminder, LYNPARZA has additional indications. This sample treatment plan template is specific to LYNPARZA in prostate cancer.
Having this new treatment option for certain patients with metastatic castration-resistant prostate cancer addresses a continued unmet medical need for this patient population and further allows the treatment team to individualize patient care.
For more information regarding the approval, please see AstraZeneca’s press release announcing the news here.
For more information about LYNPARZA includingImportant Safety Information, please see below.
IMPORTANT SAFETY INFORMATION
LYNPARZA may cause serious side effects, including:
Bone marrow problems called Myelodysplastic Syndrome (MDS) or Acute Myeloid Leukemia (AML). Some people who have ovarian cancer or breast cancer and who have received previous treatment with chemotherapy, radiotherapy, or certain other medicines for their cancer have developed MDS or AML during treatment with LYNPARZA. MDS or AML may lead to death. If you develop MDS or AML, your healthcare provider will stop treatment with LYNPARZA.
Symptoms of low blood cell counts are common during treatment with LYNPARZA, but can be a sign of serious bone marrow problems, including MDS or AML. Symptoms may include weakness, weight loss, fever, frequent infections, blood in urine or stool, shortness of breath, feeling very tired, bruising or bleeding more easily.
Your healthcare provider will do blood tests to check your blood cell counts:
· before treatment with LYNPARZA
· every month during treatment with LYNPARZA
· weekly if you have low blood cell counts that last a long time. Your healthcare provider may stop treatment with LYNPARZA until your blood cell counts improve
Lung problems (pneumonitis). Tell your healthcare provider if you have any new or worsening symptoms of lung problems, including shortness of breath, fever, cough, or wheezing. Your healthcare provider may do a chest x-ray if you have any of these symptoms. Your healthcare provider may temporarily or completely stop treatment if you develop pneumonitis. Pneumonitis may lead to death.
Blood clots (Venous Thromboembolic Events). Some people with prostate cancer who take LYNPARZA along with gonadotropin-releasing hormone (GnRH) analog therapy may develop a blood clot in a deep vein, usually in the leg (venous thrombosis) or a clot in the lung (pulmonary embolism). Tell your healthcare provider if you have any symptoms such as pain or swelling in an extremity, shortness of breath, chest pain, breathing that is more rapid than normal (tachypnea), or heart beats faster than normal (tachycardia). Your healthcare provider will monitor you for these symptoms and may prescribe blood thinner medicine.
Before taking LYNPARZA, tell your healthcare provider about all of your medical conditions, including if you:
· have lung or breathing problems
· have kidney problems
· are pregnant, become pregnant, or plan to become pregnant. LYNPARZA can harm your unborn baby and may cause loss of pregnancy (miscarriage)
- If you are able to become pregnant, your healthcare provider may do a pregnancy test before you start treatment with LYNPARZA
- Females who are able to become pregnant should use effective birth control (contraception) during treatment with LYNPARZA and for 6 months after the last dose of LYNPARZA. 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 might be pregnant following treatment with LYNPARZA
- Males with female partners who are pregnant or able to become pregnant should use effective birth control (contraception) during treatment with LYNPARZA and for 3 months after the last dose of LYNPARZA
- Do not donate sperm during treatment with LYNPARZA and for 3 months after your final dose
· are breastfeeding or plan to breastfeed. It is not known if LYNPARZA passes into your breast milk. Do not breastfeed during treatment with LYNPARZA and for 1 month after receiving the last dose of LYNPARZA. Talk to your healthcare provider about the best way to feed your baby during this time
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking LYNPARZA and certain other medicines may affect how LYNPARZA works and may cause side effects.
How should I take LYNPARZA?
· Take LYNPARZA tablets exactly as your healthcare provider tells you
· Do not change your dose or stop taking LYNPARZA unless your healthcare provider tells you to. Your healthcare provider may temporarily stop treatment with LYNPARZA or change your dose of LYNPARZA if you experience side effects
· Your healthcare provider will decide how long you stay on treatment
· Do not take more than 4 LYNPARZA tablets in 1 day. If you have any questions about LYNPARZA, talk to your healthcare provider or pharmacist
· Take LYNPARZA by mouth 2 times a day
· Each dose should be taken about 12 hours apart
· Swallow LYNPARZA tablets whole. Do not chew, crush, dissolve, or divide the tablets
· Take LYNPARZA with or without food
· If you are taking LYNPARZA for prostate cancer and you are receiving gonadotropin-releasing hormone (GnRH) analog therapy, you should continue with this treatment during your treatment with LYNPARZA unless you have had a surgery to lower the amount of testosterone in your body (surgical castration)
· If you miss a dose of LYNPARZA, take your next dose at your usual scheduled time. Do not take an extra dose to make up for a missed dose
· If you take too much LYNPARZA, call your healthcare provider or go to the nearest hospital emergency room right away
What should I avoid while taking LYNPARZA?
Avoid grapefruit, grapefruit juice, Seville oranges, and Seville orange juice during treatment with LYNPARZA since they may increase the level of LYNPARZA in your blood.
LYNPARZA may cause serious side effects (see above). The most common side effects of LYNPARZA are:
· nausea or vomiting. Tell your healthcare provider if you get nausea or vomiting. Your healthcare provider may prescribe medicines to treat these symptoms
· tiredness or weakness
· low red blood cell counts
· diarrhea
· loss of appetite
· headache
· low white blood cell counts
· changes in the way food tastes
· cough
· shortness of breath
· dizziness
· indigestion or heartburn
· low platelet counts
· upper stomach area (abdominal) pain
These are not all the possible side effects of LYNPARZA. Call your healthcare provider for medical advice about side effects.
You may report side effects related to AstraZeneca products by clicking here. If you prefer to report these to the FDA, either visit www.FDA.gov/medwatch or call 1-800-FDA-1088.
WHAT IS LYNPARZA?
LYNPARZA is a prescription medicine used to treat adults who have:
- advanced ovarian cancer, fallopian tube cancer, or primary peritoneal cancer with a certain type of inherited (germline) or acquired (somatic) abnormal BRCA gene. LYNPARZA is used alone as maintenance treatment after the cancer has responded to your first treatment with platinum-based chemotherapy. Your healthcare provider will perform a test to make sure that LYNPARZA is right for you
- advanced ovarian cancer, fallopian tube cancer, or primary peritoneal cancer with a certain type of abnormal BRCA gene or a positive laboratory tumor test for genomic instability called HRD. LYNPARZA is used in combination with another anti-cancer medicine, bevacizumab, as maintenance treatment after the cancer has responded to your first treatment with platinum-based chemotherapy. Your healthcare provider will perform a test to make sure that LYNPARZA is right for you
- ovarian cancer, fallopian tube cancer, or primary peritoneal cancer, as maintenance treatment, when the cancer has come back. LYNPARZA is used after the cancer has responded to treatment with platinum-based chemotherapy
- advanced ovarian cancer with a certain type of abnormal inherited BRCA gene, and have received treatment with 3 or more prior types of chemotherapy medicines. Your healthcare provider will perform a test to make sure that LYNPARZA is right for you
- a certain type of abnormal inherited BRCA gene, human epidermal growth factor receptor 2 (HER2)-negative breast cancer that has spread to other parts of the body (metastatic). You should have received chemotherapy medicines, either before or after your cancer has spread. If you have hormone receptor (HR)-positive disease, you should have been treated with hormonal therapy. Your healthcare provider will perform a test to make sure that LYNPARZA is right for you
- metastatic pancreatic cancer with a certain type of abnormal inherited BRCA gene. LYNPARZA is used as a maintenance treatment after your cancer has not progressed on at least 16 weeks of treatment with platinum-based chemotherapy. Your healthcare provider will perform a test to make sure LYNPARZA is right for you
- prostate cancer with certain inherited or acquired abnormal genes called homologous recombination repair (HRR genes). LYNPARZA is used when the cancer has spread to other parts of the body (metastatic), and no longer responds to a medical or surgical treatment that lowers testosterone, and has progressed after treatment with enzalutamide or abiraterone. Your healthcare provider will perform a test to make sure LYNPARZA is right for you
It is not known if LYNPARZA is safe and effective in children.
Please click here for complete Prescribing Information, including Patient Information (Medication Guide).
For more information, please visit www.lynparzahcp.com
US Food and Drug Administration (FDA) approved a new indication for LYNPARZA® (olaparib), as a treatment option for adult patients with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC) who have progressed following prior treatment with enzalutamide or abiraterone. Patients will be selected for therapy based on an FDA-approved companion diagnostic for LYNPARZA.1
The approval was based on results from the Phase III PROfound trial, published in the New England Journal of Medicine, which showed LYNPARZA reduced the risk of disease progression or death by 66% (equal to a hazard ratio of 0.34 and p-value of <0.0001) and improved radiographic progression-free survival (rPFS) to a median of 7.4 versus 3.6 months with enzalutamide or abiraterone in men with BRCA1/2 or ATM gene-mutated mCRPC.1 Additionally, results showed:
- A statistically significant improvement in the select secondary endpoint of overall survival (OS) in men with BRCA1/2 or ATM gene-mutated mCRPC. LYNPARZA reduced the risk of death by 31% (equal to a hazard ratio of 0.69 and p-value 0.0175) and improved OS to a median of 19.1 months versus 14.7 months for those treated with enzalutamide or abiraterone.1
- A statistically significant improvement in objective response rate of 33% in men with BRCA1/2 or ATM gene-mutated mCRPC treated with LYNPARZA vs 2% treated with enzalutamide or abiraterone (p-value of <0.0001).1
- In men with HRR-mutated mCRPC, LYNPARZA reduced the risk of disease progression or death by 51% (equal to a hazard ratio of 0.49 and p-value of <0.0001) and improved rPFS to a median of 5.8 months versus 3.5 months with abiraterone or enzalutamide.1
Fatal adverse reactions occurred in 4% of patients treated with LYNPARZA. These included pneumonia (1.2%), cardiopulmonary failure (0.4%), aspiration pneumonia (0.4%), intestinal diverticulum (0.4%), septic shock (0.4%), Budd-Chiari Syndrome (0.4%), sudden death (0.4%), and acute cardiac failure (0.4%).1 Serious adverse reactions occurred in 36% of patients receiving LYNPARZA. Serious adverse reactions in ≥2% were anemia (9%), pneumonia (4%), pulmonary embolism (2%), fatigue/asthenia (2%), and urinary tract infection (2%).1
The most common adverse reactions (Grade 1-4) occurring in ≥10% in the LYNPARZA arm (N=256) were anemia (46%), nausea (41%), fatigue including asthenia (41%), decreased appetite (30%), diarrhea (21%), vomiting (18%), thrombocytopenia (12%), cough (11%) and dyspnea (10%).1
In addition, venous thromboembolic events, including pulmonary embolism, occurred in 7% of patients with metastatic castration-resistant prostate cancer who received LYNPARZA plus androgen deprivation therapy (ADT) compared to 3.1% of patients receiving enzalutamide or abiraterone plus ADT in the PROfound study. Patients receiving LYNPARZA and ADT had a 6% incidence of pulmonary embolism compared to 0.8% of patients treated with ADT plus either enzalutamide or abiraterone.1
This is the seventh indication approved for LYNPARZA in the US, making it the first targeted therapy in men with metastatic castration-resistant prostate cancer with HRR gene mutations to be approved by the FDA based on a Phase III trial. LYNPARZA is associated with serious, potentially fatal risks, including myelodysplastic syndrome/acute myeloid leukemia (MDS/AML), pneumonitis and venous thromboembolic events. LYNPARZA can also cause fetal harm. Please see additional Important Safety Information below.
Included in this email is a LYNPARZA sample treatment plan template for the new indication in prostate cancer. This is an example of an Electronic Health Record (EHR) order set.
As a reminder, LYNPARZA has additional indications. This sample treatment plan template is specific to LYNPARZA in prostate cancer.
Having this new treatment option for certain patients with metastatic castration-resistant prostate cancer addresses a continued unmet medical need for this patient population and further allows the treatment team to individualize patient care.
For more information regarding the approval, please see AstraZeneca’s press release announcing the news here.
For more information about LYNPARZA includingImportant Safety Information, please see below.
IMPORTANT SAFETY INFORMATION
LYNPARZA may cause serious side effects, including:
Bone marrow problems called Myelodysplastic Syndrome (MDS) or Acute Myeloid Leukemia (AML). Some people who have ovarian cancer or breast cancer and who have received previous treatment with chemotherapy, radiotherapy, or certain other medicines for their cancer have developed MDS or AML during treatment with LYNPARZA. MDS or AML may lead to death. If you develop MDS or AML, your healthcare provider will stop treatment with LYNPARZA.
Symptoms of low blood cell counts are common during treatment with LYNPARZA, but can be a sign of serious bone marrow problems, including MDS or AML. Symptoms may include weakness, weight loss, fever, frequent infections, blood in urine or stool, shortness of breath, feeling very tired, bruising or bleeding more easily.
Your healthcare provider will do blood tests to check your blood cell counts:
· before treatment with LYNPARZA
· every month during treatment with LYNPARZA
· weekly if you have low blood cell counts that last a long time. Your healthcare provider may stop treatment with LYNPARZA until your blood cell counts improve
Lung problems (pneumonitis). Tell your healthcare provider if you have any new or worsening symptoms of lung problems, including shortness of breath, fever, cough, or wheezing. Your healthcare provider may do a chest x-ray if you have any of these symptoms. Your healthcare provider may temporarily or completely stop treatment if you develop pneumonitis. Pneumonitis may lead to death.
Blood clots (Venous Thromboembolic Events). Some people with prostate cancer who take LYNPARZA along with gonadotropin-releasing hormone (GnRH) analog therapy may develop a blood clot in a deep vein, usually in the leg (venous thrombosis) or a clot in the lung (pulmonary embolism). Tell your healthcare provider if you have any symptoms such as pain or swelling in an extremity, shortness of breath, chest pain, breathing that is more rapid than normal (tachypnea), or heart beats faster than normal (tachycardia). Your healthcare provider will monitor you for these symptoms and may prescribe blood thinner medicine.
Before taking LYNPARZA, tell your healthcare provider about all of your medical conditions, including if you:
· have lung or breathing problems
· have kidney problems
· are pregnant, become pregnant, or plan to become pregnant. LYNPARZA can harm your unborn baby and may cause loss of pregnancy (miscarriage)
- If you are able to become pregnant, your healthcare provider may do a pregnancy test before you start treatment with LYNPARZA
- Females who are able to become pregnant should use effective birth control (contraception) during treatment with LYNPARZA and for 6 months after the last dose of LYNPARZA. 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 might be pregnant following treatment with LYNPARZA
- Males with female partners who are pregnant or able to become pregnant should use effective birth control (contraception) during treatment with LYNPARZA and for 3 months after the last dose of LYNPARZA
- Do not donate sperm during treatment with LYNPARZA and for 3 months after your final dose
· are breastfeeding or plan to breastfeed. It is not known if LYNPARZA passes into your breast milk. Do not breastfeed during treatment with LYNPARZA and for 1 month after receiving the last dose of LYNPARZA. Talk to your healthcare provider about the best way to feed your baby during this time
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking LYNPARZA and certain other medicines may affect how LYNPARZA works and may cause side effects.
How should I take LYNPARZA?
· Take LYNPARZA tablets exactly as your healthcare provider tells you
· Do not change your dose or stop taking LYNPARZA unless your healthcare provider tells you to. Your healthcare provider may temporarily stop treatment with LYNPARZA or change your dose of LYNPARZA if you experience side effects
· Your healthcare provider will decide how long you stay on treatment
· Do not take more than 4 LYNPARZA tablets in 1 day. If you have any questions about LYNPARZA, talk to your healthcare provider or pharmacist
· Take LYNPARZA by mouth 2 times a day
· Each dose should be taken about 12 hours apart
· Swallow LYNPARZA tablets whole. Do not chew, crush, dissolve, or divide the tablets
· Take LYNPARZA with or without food
· If you are taking LYNPARZA for prostate cancer and you are receiving gonadotropin-releasing hormone (GnRH) analog therapy, you should continue with this treatment during your treatment with LYNPARZA unless you have had a surgery to lower the amount of testosterone in your body (surgical castration)
· If you miss a dose of LYNPARZA, take your next dose at your usual scheduled time. Do not take an extra dose to make up for a missed dose
· If you take too much LYNPARZA, call your healthcare provider or go to the nearest hospital emergency room right away
What should I avoid while taking LYNPARZA?
Avoid grapefruit, grapefruit juice, Seville oranges, and Seville orange juice during treatment with LYNPARZA since they may increase the level of LYNPARZA in your blood.
LYNPARZA may cause serious side effects (see above). The most common side effects of LYNPARZA are:
· nausea or vomiting. Tell your healthcare provider if you get nausea or vomiting. Your healthcare provider may prescribe medicines to treat these symptoms
· tiredness or weakness
· low red blood cell counts
· diarrhea
· loss of appetite
· headache
· low white blood cell counts
· changes in the way food tastes
· cough
· shortness of breath
· dizziness
· indigestion or heartburn
· low platelet counts
· upper stomach area (abdominal) pain
These are not all the possible side effects of LYNPARZA. Call your healthcare provider for medical advice about side effects.
You may report side effects related to AstraZeneca products by clicking here. If you prefer to report these to the FDA, either visit www.FDA.gov/medwatch or call 1-800-FDA-1088.
WHAT IS LYNPARZA?
LYNPARZA is a prescription medicine used to treat adults who have:
- advanced ovarian cancer, fallopian tube cancer, or primary peritoneal cancer with a certain type of inherited (germline) or acquired (somatic) abnormal BRCA gene. LYNPARZA is used alone as maintenance treatment after the cancer has responded to your first treatment with platinum-based chemotherapy. Your healthcare provider will perform a test to make sure that LYNPARZA is right for you
- advanced ovarian cancer, fallopian tube cancer, or primary peritoneal cancer with a certain type of abnormal BRCA gene or a positive laboratory tumor test for genomic instability called HRD. LYNPARZA is used in combination with another anti-cancer medicine, bevacizumab, as maintenance treatment after the cancer has responded to your first treatment with platinum-based chemotherapy. Your healthcare provider will perform a test to make sure that LYNPARZA is right for you
- ovarian cancer, fallopian tube cancer, or primary peritoneal cancer, as maintenance treatment, when the cancer has come back. LYNPARZA is used after the cancer has responded to treatment with platinum-based chemotherapy
- advanced ovarian cancer with a certain type of abnormal inherited BRCA gene, and have received treatment with 3 or more prior types of chemotherapy medicines. Your healthcare provider will perform a test to make sure that LYNPARZA is right for you
- a certain type of abnormal inherited BRCA gene, human epidermal growth factor receptor 2 (HER2)-negative breast cancer that has spread to other parts of the body (metastatic). You should have received chemotherapy medicines, either before or after your cancer has spread. If you have hormone receptor (HR)-positive disease, you should have been treated with hormonal therapy. Your healthcare provider will perform a test to make sure that LYNPARZA is right for you
- metastatic pancreatic cancer with a certain type of abnormal inherited BRCA gene. LYNPARZA is used as a maintenance treatment after your cancer has not progressed on at least 16 weeks of treatment with platinum-based chemotherapy. Your healthcare provider will perform a test to make sure LYNPARZA is right for you
- prostate cancer with certain inherited or acquired abnormal genes called homologous recombination repair (HRR genes). LYNPARZA is used when the cancer has spread to other parts of the body (metastatic), and no longer responds to a medical or surgical treatment that lowers testosterone, and has progressed after treatment with enzalutamide or abiraterone. Your healthcare provider will perform a test to make sure LYNPARZA is right for you
It is not known if LYNPARZA is safe and effective in children.
Please click here for complete Prescribing Information, including Patient Information (Medication Guide).
For more information, please visit www.lynparzahcp.com
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