Keytruda
I was told I had stage 4, back in April 2016 ,and was given the impression that I had a couple of months. I knew he was wrong. He was so sure of himself that after I had surgery to remove uterus and ovaries and follow up, I left him and found a better doctor and clinic. This doctor started me on three months of chemo back in Aug 2016. I handled that pretty good and marker went down to 4. But it started to rise. So about Oct 2016 I was put on Dixol - had no trouble with that one but it didn't do the trick. Than placed on hormone pills. In August 2017 I was placed on Keytruda with the marker at 176 and as of today after two treatments it is down to 26. Keytruda has just been approved for ovarian cancer and I would just like to pass this information on. So far the only side effect was the swelling of tongue and Bendryl is taking care of that problem.
Comments
-
Travlinlady~R U SURE KEYTRUDA has FDA approval for OC~Need2 know
Good morning “Travlinlady”
We are all eager to learn of any new FDA approval of drugs for Ovarian cancer. When was KEYTRUDA approved for Ovarian cancer?
Could you possibly be mistaken about FDA approval? Please send me a “verification”. I can’t seem to find where it has been approved by the FDA. Could it be that you have been placed on a “clinical trial” involving Keytruda?
Only 2 weeks ago, I was at a consultation with my oncologist. He wrote a list of drugs that I could choose from and KEYTRUDA was not one of them. He talked about possible clinical trials and Keytruda wasn’t in that group either. I’ll be at my doctor’s office again tomorrow and I will certainly want to inquire about this? I know it’s been approved for other cancers. I am at the point of choosing to go on another round of approved FDA drugs for my Stage IV Peritoneal Carcinomatosis/Ovarian Cancer, or choose a clinical trial.
So please let me know when Keytruda was approved by the FDA for Ovarian Cancer.
Glad to know it’s working for you. I’ve read about some very good results with this drug and I’ve read some bad things about DOXIL, so much so that I’ve ruled Doxil OUT!
“Need to know for sure”
Loretta
______________________________________________________________
1. https://www.cancer.gov/about-cancer/treatment/drugs/ovarian#1
Drugs Approved for Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
This page lists cancer drugs approved by the Food and Drug Administration (FDA) for ovarian, fallopian tube, or primary peritoneal cancer. The list includes generic and brand names. This page also lists common drug combinations used in these cancer types. The individual drugs in the combinations are FDA-approved. However, drug combinations themselves usually are not approved, but are widely used.
The drug names link to NCI's Cancer Drug Information summaries. There may be drugs used in ovarian, fallopian tube, or primary peritoneal cancer that are not listed here.
On This Page
- Drugs Approved for Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
- Drug Combinations Used in Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
___________________________________________________________________
2. https://www.keytruda.com/?cc=F56EF8DC&csid=General_Brand_Lung&gclid=CP2Vq__9s9YCFc6Lswod4HgBuA
[My note: The “bold and underlining” are mine.”
“…KEYTRUDA is a prescription medicine used to treat:- a kind of skin cancer called melanoma. It may be used when your melanoma has spread or cannot be removed by surgery (advanced melanoma).
- a kind of lung cancer called non–small cell lung cancer (NSCLC).
o It may be used alone as your first treatment when your lung cancer has spread (advanced NSCLC) and tests positive for “PD-L1” and your tumor does not have an abnormal “EGFR” or “ALK” gene.
o It may also be used alone for advanced NSCLC if you have tried chemotherapy that contains platinum and it did not work or is no longer working and your lung cancer tests positive for “PD-L1” and, if your tumor has an abnormal “EGFR” or “ALK” gene, you have also received an “EGFR” or “ALK” inhibitor medicine that did not work or is no longer working.
- a kind of cancer called head and neck squamous cell cancer (HNSCC). It may be used when your HNSCC has returned or spread and you have received chemotherapy that contains platinum and it did not work or is no longer working.
- a kind of cancer called classical Hodgkin lymphoma (cHL). KEYTRUDA may be used for cHL in adults and children when you have tried a treatment and it did not work or when your cHL has returned after you received 3 or more types of treatment.
- a kind of bladder or urinary tract cancer when it has spread or cannot be removed by surgery (advanced urothelial cancer) and you are not able to receive chemotherapy that contains a medicine called cisplatin, or you have received chemotherapy that contains platinum, and it did not work or is no longer working.
- a kind of cancer that is shown by a laboratory test to be a microsatellite instability-high (MSI-H) or a mismatch repair deficient (dMMR) solid tumor. KEYTRUDA may be used in adults and children to treat:
o cancer that has spread or cannot be removed by surgery (advanced cancer), and
o has progressed following treatment, and you have no satisfactory treatment options, or
o you have colon or rectal cancer, and you have received chemotherapy with fluoropyrimidine, oxaliplatin, and irinotecan but it did not work or is no longer working.
It is not known if KEYTRUDA is safe and effective in children with MSI-H cancers of the brain or spinal cord (central nervous system cancers).
PD-L1 = programmed death ligand 1; EGFR = epidermal growth factor receptor; ALK = anaplastic lymphoma kinase…”
Important Safety Information About KEYTRUDA® (pembrolizumab)
_________________________End of references___________________
0 -
Keytruda seems to be approvedLorettaMarshall said:Travlinlady~R U SURE KEYTRUDA has FDA approval for OC~Need2 know
Good morning “Travlinlady”
We are all eager to learn of any new FDA approval of drugs for Ovarian cancer. When was KEYTRUDA approved for Ovarian cancer?
Could you possibly be mistaken about FDA approval? Please send me a “verification”. I can’t seem to find where it has been approved by the FDA. Could it be that you have been placed on a “clinical trial” involving Keytruda?
Only 2 weeks ago, I was at a consultation with my oncologist. He wrote a list of drugs that I could choose from and KEYTRUDA was not one of them. He talked about possible clinical trials and Keytruda wasn’t in that group either. I’ll be at my doctor’s office again tomorrow and I will certainly want to inquire about this? I know it’s been approved for other cancers. I am at the point of choosing to go on another round of approved FDA drugs for my Stage IV Peritoneal Carcinomatosis/Ovarian Cancer, or choose a clinical trial.
So please let me know when Keytruda was approved by the FDA for Ovarian Cancer.
Glad to know it’s working for you. I’ve read about some very good results with this drug and I’ve read some bad things about DOXIL, so much so that I’ve ruled Doxil OUT!
“Need to know for sure”
Loretta
______________________________________________________________
1. https://www.cancer.gov/about-cancer/treatment/drugs/ovarian#1
Drugs Approved for Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
This page lists cancer drugs approved by the Food and Drug Administration (FDA) for ovarian, fallopian tube, or primary peritoneal cancer. The list includes generic and brand names. This page also lists common drug combinations used in these cancer types. The individual drugs in the combinations are FDA-approved. However, drug combinations themselves usually are not approved, but are widely used.
The drug names link to NCI's Cancer Drug Information summaries. There may be drugs used in ovarian, fallopian tube, or primary peritoneal cancer that are not listed here.
On This Page
- Drugs Approved for Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
- Drug Combinations Used in Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
___________________________________________________________________
2. https://www.keytruda.com/?cc=F56EF8DC&csid=General_Brand_Lung&gclid=CP2Vq__9s9YCFc6Lswod4HgBuA
[My note: The “bold and underlining” are mine.”
“…KEYTRUDA is a prescription medicine used to treat:- a kind of skin cancer called melanoma. It may be used when your melanoma has spread or cannot be removed by surgery (advanced melanoma).
- a kind of lung cancer called non–small cell lung cancer (NSCLC).
o It may be used alone as your first treatment when your lung cancer has spread (advanced NSCLC) and tests positive for “PD-L1” and your tumor does not have an abnormal “EGFR” or “ALK” gene.
o It may also be used alone for advanced NSCLC if you have tried chemotherapy that contains platinum and it did not work or is no longer working and your lung cancer tests positive for “PD-L1” and, if your tumor has an abnormal “EGFR” or “ALK” gene, you have also received an “EGFR” or “ALK” inhibitor medicine that did not work or is no longer working.
- a kind of cancer called head and neck squamous cell cancer (HNSCC). It may be used when your HNSCC has returned or spread and you have received chemotherapy that contains platinum and it did not work or is no longer working.
- a kind of cancer called classical Hodgkin lymphoma (cHL). KEYTRUDA may be used for cHL in adults and children when you have tried a treatment and it did not work or when your cHL has returned after you received 3 or more types of treatment.
- a kind of bladder or urinary tract cancer when it has spread or cannot be removed by surgery (advanced urothelial cancer) and you are not able to receive chemotherapy that contains a medicine called cisplatin, or you have received chemotherapy that contains platinum, and it did not work or is no longer working.
- a kind of cancer that is shown by a laboratory test to be a microsatellite instability-high (MSI-H) or a mismatch repair deficient (dMMR) solid tumor. KEYTRUDA may be used in adults and children to treat:
o cancer that has spread or cannot be removed by surgery (advanced cancer), and
o has progressed following treatment, and you have no satisfactory treatment options, or
o you have colon or rectal cancer, and you have received chemotherapy with fluoropyrimidine, oxaliplatin, and irinotecan but it did not work or is no longer working.
It is not known if KEYTRUDA is safe and effective in children with MSI-H cancers of the brain or spinal cord (central nervous system cancers).
PD-L1 = programmed death ligand 1; EGFR = epidermal growth factor receptor; ALK = anaplastic lymphoma kinase…”
Important Safety Information About KEYTRUDA® (pembrolizumab)
_________________________End of references___________________
Keytruda seems to be approved for any solid tumor cancers which include ovarian. Tumor needs to have a certain bio marker though.
https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm560167.htm
0 -
U R right-Only approved 4 a specific genetic marker not 4 all OC
Hello “Worried Husband” ~
It’s good to hear from you again. We’ve spoken earlier on this forum.
According to your reference, Keytruda doesn’t appear to be “widely” approved for Ovarian Cancer patients. This news article specifically states that it is only for a “specific genetic feature.” So while I’m pleased to know that the government is actually working on “something” in an accelerated fashion. As I read this article, it is LIMITED, and not for everyone who has been diagnosed with Ovarian cancer. I will certainly seek clarification from my oncologist tomorrow.
Still need to know more –
Loretta
______________________________________________________________
1. https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm560167.htm
FDA News Release
FDA approves first cancer treatment for any solid tumor with a specific genetic feature
For Immediate Release
May 23, 2017
Release
The U.S. Food and Drug Administration today granted accelerated approval to a treatment for patients whose cancers have a specific genetic feature (biomarker). This is the first time the agency has approved a cancer treatment based on a common biomarker rather than the location in the body where the tumor originated.
Keytruda (pembrolizumab) is indicated for the treatment of adult and pediatric patients with unresectable or metastatic solid tumors that have been identified as having a biomarker referred to as microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR).
This indication covers patients with solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options and patients with colorectal cancer that has progressed following treatment with certain chemotherapy drugs.
“This is an important first for the cancer community,” said Richard Pazdur, M.D., acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research and director of the FDA’s Oncology Center of Excellence. “Until now, the FDA has approved cancer treatments based on where in the body the cancer started—for example, lung or breast cancers. We have now approved a drug based on a tumor’s biomarker without regard to the tumor’s original location.”
MSI-H and dMMR tumors contain abnormalities that affect the proper repair of DNA inside the cell.
Tumors with these biomarkers are most commonly found in colorectal, endometrial and gastrointestinal cancers, but also less commonly appear in cancers arising in the breast, prostate, bladder, thyroid gland and other places.
Approximately 5 percent of patients with metastatic colorectal cancer have MSI-H or dMMR tumors.
Keytruda works by targeting the cellular pathway known as PD-1/PD-L1 (proteins found on the body’s immune cells and some cancer cells). By blocking this pathway, Keytruda may help the body’s immune system fight the cancer cells.
The FDA previously approved Keytruda for the treatment of certain patients with metastatic melanoma, metastatic non-small cell lung cancer, recurrent or metastatic head and neck cancer, refractory classical Hodgkin lymphoma, and urothelial carcinoma.
Keytruda was approved for this new indication using the Accelerated Approval pathway, under which the FDA may approve drugs for serious conditions where there is unmet medical need and a drug is shown to have certain effects that are reasonably likely to predict a clinical benefit to patients.
Further study is required to verify and describe anticipated clinical benefits of Keytruda, and the sponsor is currently conducting these studies in additional patients with MSI-H or dMMR tumors.
The safety and efficacy of Keytruda for this indication were studied in patients with MSI-H or dMMR solid tumors enrolled in one of five uncontrolled, single-arm clinical trials.
In some trials, patients were required to have MSI-H or dMMR cancers, while in other trials, a subgroup of patients were identified as having MSI-H or dMMR cancers by testing tumor samples after treatment began.
A total of 15 cancer types were identified among 149 patients enrolled across these five clinical trials. The most common cancers were colorectal, endometrial and other gastrointestinal cancers.
The review of Keytruda for this indication was based on the percentage of patients who experienced complete or partial shrinkage of their tumors (overall response rate) and for how long (durability of response). Of the 149 patients who received Keytruda in the trials, 39.6 percent had a complete or partial response. For 78 percent of those patients, the response lasted for six months or more.
Common side effects of Keytruda include fatigue, itchy skin (pruritus), diarrhea, decreased appetite, rash, fever (pyrexia), cough, difficulty breathing (dyspnea), musculoskeletal pain, constipation and nausea. Keytruda can cause serious conditions known as immune-mediated side effects, including inflammation of healthy organs such as the lungs (pneumonitis), colon (colitis), liver (hepatitis), endocrine glands (endocrinopathies) and kidneys (nephritis). Complications or death related to allogeneic hematopoietic stem cell transplantation after using Keytruda has occurred.
Patients who experience severe or life-threatening infusion-related reactions should stop taking Keytruda. Women who are pregnant or breastfeeding should not take Keytruda because it may cause harm to a developing fetus or newborn baby. The safety and effectiveness of Keytruda in pediatric patients with MSI-H central nervous system cancers have not been established.
The FDA granted this application Priority Review designation, under which the FDA’s goal is to take action on an application within six months where the agency determines that the drug, if approved, would significantly improve the safety or effectiveness of treating, diagnosing or preventing a serious condition.
The FDA granted accelerated approval of Keytruda to Merck & Co.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products…”
###
Inquiries
Media
Angela Stark
301-796-0397Consumers
888-INFO-FDA
Related Information
- FDA: Office of Hematology and Oncology Products
- FDA: Approved Drugs: Questions and Answers
- FDA: Fast Track, Breakthrough Therapy, Accelerated Approval, and Priority Review
Follow FDA
0 -
Genetic & Functional Profiling
Loretta,
As in the case with Keytruda, there are many drugs out there that target specific tumor profiles.
However, GYNONCs rely on general guidelines and protocols that cannot capture each patient's unique features e.g. carbo/taxol for all.
Sometimes patients get treated with toxic agents only to find out it's not working for them, then the physician tries another agent. Valuable time is waisted and the patient's immune system is destroyed for nothing.
All ovarian cancer patients should ask their oncs to get their tumors genetically profiled to find the best treatment option. Many drugs, drug combinations and targeted agents are used to treat OVCA and drugs that work for one patient may not work for another. Genetic blueprinting of the tumor can guide treatment plans.
Another method called Functional Profiling (of the tumor) which is a laboratory technique that measures how patient's cancer cells respond when they are exposed to drugs and drug combinations. This helps discover the most effective and least toxic drug regimen prior to initiating treatment.
I think the cancer treatment should be targeted and individualized.
For example, it would be great if patients' tumors were to be tested prior to initiating platinum based treatment to see if their tumor is platinum sensitive.
0 -
Thanks Loretta for anserwingLorettaMarshall said:Travlinlady~R U SURE KEYTRUDA has FDA approval for OC~Need2 know
Good morning “Travlinlady”
We are all eager to learn of any new FDA approval of drugs for Ovarian cancer. When was KEYTRUDA approved for Ovarian cancer?
Could you possibly be mistaken about FDA approval? Please send me a “verification”. I can’t seem to find where it has been approved by the FDA. Could it be that you have been placed on a “clinical trial” involving Keytruda?
Only 2 weeks ago, I was at a consultation with my oncologist. He wrote a list of drugs that I could choose from and KEYTRUDA was not one of them. He talked about possible clinical trials and Keytruda wasn’t in that group either. I’ll be at my doctor’s office again tomorrow and I will certainly want to inquire about this? I know it’s been approved for other cancers. I am at the point of choosing to go on another round of approved FDA drugs for my Stage IV Peritoneal Carcinomatosis/Ovarian Cancer, or choose a clinical trial.
So please let me know when Keytruda was approved by the FDA for Ovarian Cancer.
Glad to know it’s working for you. I’ve read about some very good results with this drug and I’ve read some bad things about DOXIL, so much so that I’ve ruled Doxil OUT!
“Need to know for sure”
Loretta
______________________________________________________________
1. https://www.cancer.gov/about-cancer/treatment/drugs/ovarian#1
Drugs Approved for Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
This page lists cancer drugs approved by the Food and Drug Administration (FDA) for ovarian, fallopian tube, or primary peritoneal cancer. The list includes generic and brand names. This page also lists common drug combinations used in these cancer types. The individual drugs in the combinations are FDA-approved. However, drug combinations themselves usually are not approved, but are widely used.
The drug names link to NCI's Cancer Drug Information summaries. There may be drugs used in ovarian, fallopian tube, or primary peritoneal cancer that are not listed here.
On This Page
- Drugs Approved for Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
- Drug Combinations Used in Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
___________________________________________________________________
2. https://www.keytruda.com/?cc=F56EF8DC&csid=General_Brand_Lung&gclid=CP2Vq__9s9YCFc6Lswod4HgBuA
[My note: The “bold and underlining” are mine.”
“…KEYTRUDA is a prescription medicine used to treat:- a kind of skin cancer called melanoma. It may be used when your melanoma has spread or cannot be removed by surgery (advanced melanoma).
- a kind of lung cancer called non–small cell lung cancer (NSCLC).
o It may be used alone as your first treatment when your lung cancer has spread (advanced NSCLC) and tests positive for “PD-L1” and your tumor does not have an abnormal “EGFR” or “ALK” gene.
o It may also be used alone for advanced NSCLC if you have tried chemotherapy that contains platinum and it did not work or is no longer working and your lung cancer tests positive for “PD-L1” and, if your tumor has an abnormal “EGFR” or “ALK” gene, you have also received an “EGFR” or “ALK” inhibitor medicine that did not work or is no longer working.
- a kind of cancer called head and neck squamous cell cancer (HNSCC). It may be used when your HNSCC has returned or spread and you have received chemotherapy that contains platinum and it did not work or is no longer working.
- a kind of cancer called classical Hodgkin lymphoma (cHL). KEYTRUDA may be used for cHL in adults and children when you have tried a treatment and it did not work or when your cHL has returned after you received 3 or more types of treatment.
- a kind of bladder or urinary tract cancer when it has spread or cannot be removed by surgery (advanced urothelial cancer) and you are not able to receive chemotherapy that contains a medicine called cisplatin, or you have received chemotherapy that contains platinum, and it did not work or is no longer working.
- a kind of cancer that is shown by a laboratory test to be a microsatellite instability-high (MSI-H) or a mismatch repair deficient (dMMR) solid tumor. KEYTRUDA may be used in adults and children to treat:
o cancer that has spread or cannot be removed by surgery (advanced cancer), and
o has progressed following treatment, and you have no satisfactory treatment options, or
o you have colon or rectal cancer, and you have received chemotherapy with fluoropyrimidine, oxaliplatin, and irinotecan but it did not work or is no longer working.
It is not known if KEYTRUDA is safe and effective in children with MSI-H cancers of the brain or spinal cord (central nervous system cancers).
PD-L1 = programmed death ligand 1; EGFR = epidermal growth factor receptor; ALK = anaplastic lymphoma kinase…”
Important Safety Information About KEYTRUDA® (pembrolizumab)
_________________________End of references___________________
Thanks Loretta for anserwing "Worried Husband" for me. My response would have been to late for him to ask about this with the doctor since his appointment was the next day. I have found a good doctor that will not use something or continue with rounds of chemo if he didn't feel like it was going to help. I knew about Keytruda being approved and the next appointment we brought it up and he already was given us the information on it to see if I would like to use it. He said he checked and double checked my results of the genes to see if I could use it. To be truthful, even if he didn't suggest, I would have brought it up and told him I would want to try. I also take herbs to build up my immune system and I belive that helps also. The herbs I use are turmeric, iron pills, calcuim C, boswelli, veg and fruit capsules, real mushrooms - 5 defenders, ginger root, raw organic dandelion root tea and selenium. Plus I rub on a mixture of coconut and boswelli in liquid form all over the stomach nightly. But the one true thing that works is my faith in God, I thank him daily for His help and do not question why I have it. He gave it to me for a reason.
0 -
Update on Keytruda?
Hi Travlinlady,
I was wondering if you had an update on how you are doing on Keytruda?
And do you know what sub-type of OVCA you have? As you've had hormone therapy I was wondering if it was low-grade?
I'm trying to find any information on immunotherapy success stories and low-grade OVCA
All the best!! Elsa 0
Discussion Boards
- All Discussion Boards
- 6 CSN Information
- 6 Welcome to CSN
- 121.9K Cancer specific
- 2.8K Anal Cancer
- 446 Bladder Cancer
- 309 Bone Cancers
- 1.6K Brain Cancer
- 28.5K Breast Cancer
- 398 Childhood Cancers
- 27.9K Colorectal Cancer
- 4.6K Esophageal Cancer
- 1.2K Gynecological Cancers (other than ovarian and uterine)
- 13K Head and Neck Cancer
- 6.4K Kidney Cancer
- 671 Leukemia
- 794 Liver Cancer
- 4.1K Lung Cancer
- 5.1K Lymphoma (Hodgkin and Non-Hodgkin)
- 237 Multiple Myeloma
- 7.1K Ovarian Cancer
- 63 Pancreatic Cancer
- 487 Peritoneal Cancer
- 5.5K Prostate Cancer
- 1.2K Rare and Other Cancers
- 540 Sarcoma
- 733 Skin Cancer
- 653 Stomach Cancer
- 191 Testicular Cancer
- 1.5K Thyroid Cancer
- 5.8K Uterine/Endometrial Cancer
- 6.3K Lifestyle Discussion Boards