Category: Mesothelioma
First-Ever FDA Approval of Anti-Cancer Drug Based on Biomarker and Not Cancer Type Is Encouraging for Mesothelioma Patients
Last week MesotheliomaHelp reported on the drive towards using DNA sequencing on cancer patients in an effort to determine the appropriate treatment based on the patients’ biomarkers. Keytruda, that targets the PD-L1 marker, was cited as an example in that article. Now, the U.S. Food and Drug Administration has granted accelerated approval to Keytruda as a treatment based solely on the genetic mutations of a cancer and not on the type of cancer.
The FDA announced in a May 23 press release, that this is the first-ever approval of a cancer treatment based on a common biomarker rather than the location in the body where the tumor originated. Keytruda has already been approved for in the U.S. for use in melanoma and lung cancer patients after a prior round of chemotherapy failed to stop progression of the disease. This approval is for unresectable or metastatic solid tumors, of any type, that have been identified as having a biomarker referred to as microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR).
Expert Insight
Richard Pazdur, M.D., FDA
“This is an important first for the cancer community.”
“Until now, the FDA has approved cancer treatments based on where in the body the cancer started—for example, lung or breast cancers,” 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. “We have now approved a drug based on a tumor’s biomarker without regard to the tumor’s original location.”
This approval, according to the FDA, was based on the results of five clinical trials for patients with MSI-H or dMMR solid tumors. The patients had a variety of cancers, including colorectal and endometrial. Of the 149 patients who received Keytruda in the trials, nearly 40 percent had a complete or partial response, with 78 percent of those patients seeing a lasting response for six months or longer.
“The FDA’s approval of this first-of-its-kind, tumor-agnostic, indication is further evidence of Merck’s commitment to helping people with difficult-to-treat cancers, and to advancing the use of biomarkers to guide clinical decision-making,” said Dr. Roger M. Perlmutter, president, Merck Research Laboratories, in a May 25 press release announcing the approval.
This approval has far-reaching implications for the mesothelioma community for future approvals of biomarker-driven drugs. Significant research has been conducted to find those biomarkers that drive the uncontrollable growth of mesothelioma, and other cancers, and this landmark approval moves oncologists much closer to offering personalized care. Targeted therapy improves quality of life and increases survival for cancer patients.
“This approval for Keytruda is a transformational milestone in our progress toward personalized immunotherapy, offering certain patients with difficult-to-treat cancers a medicine based on the genetic makeup of the tumor – regardless of tumor type,” said Dr. Luis A. Diaz, Jr., head of the Division of Solid Tumor Oncology, Memorial Sloan Kettering Cancer Center.
Mesothelioma is an asbestos-caused cancer with a prognosis often less than 18-months. New, effective treatment options are critically important to allow patients to live longer lives.
Patients should talk to their oncologists to determine whether Keytruda is a treatment option for them. Visit the Keytruda website to find out more about the drug.
Sources:
- FDA
https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm560167.htm - Merck Research Laboratories
http://www.mrknewsroom.com/news-release/prescription-medicine-news/fda-approves-mercks-keytruda-pembrolizumab-adult-and-pediatr - Keytruda website
https://www.keytruda.com/?cc=F56EF8DC&csid=General_Brand_Lung&gclid=CjwKEAjw4IjKBRDr6p752cCUm3kSJAC-eqRtAmMqxwdRx6gjIkSciP4aQ8fZl3M5fzF-2jLSDG5kmhoCzVbw_wcB
Targeted Therapy May Soon be Primary Approach for Mesothelioma Treatment
Targeted care optimizes the potential for success of mesothelioma treatment and provides the patient with the assurance that his cancer is being treated according to his unique characteristics. Personalized cancer treatment is gaining popularity among physicians and oncologists, however, it is far from mainstream. If researchers from University of Michigan have their way, however, treatment for all cancers will soon be personalized based on the patient’s biomarkers.
In a new study released from researchers at the University of Michigan Comprehensive Cancer Center, the team looked at the DNA sequencing of nearly 500 patients. Of those, almost 75 percent of them had biomarkers that can be targeted by either existing or experimental anti-cancer treatments.
Biomarkers, including EGFR and PD-L1, that are present in mesothelioma and other cancers, help indicate the reason for the growth of the cancers and are the focus of current and experimental treatments used to fight the deadly disease. Many clinical trials are being offered now for mesothelioma patients that pinpoint particular biomarkers. One well-known trial is the Keynote-28 trial, that eight-year mesothelioma survivor Mavis Nye of England participated in, that targeted the PD-L1 marker and put her mesothelioma in remission.
“Availability of biomarker trials is crucial for being able to act on these results,” says Erin Cobain, M.D., clinical lecturer of hematology/oncology at the University of Michigan Medical School.
The value of the study lies in the method used to sequence the genes and the process for developing patient care based on the results of the sequencing. Using “next generation sequencing” the team reports that the genetic sequencing looks at all of the DNA and RNA expressed within a tumor, as well as sequencing the patient’s normal genome to identify genes that may be inherited from the patient’s parents.
Expert Insight
Erin Cobain, M.D., University of Michigan
Sequencing is beginning to have a real impact on treatment recommendations.”
Using MI-ONCOSEQ, the tool developed at the Michigan Oncology Sequencing Center, the test uses a fresh biopsy from the patient, as opposed to frozen tissue samples used by commercially-available tools, allowing the Michigan researchers to perform a more comprehensive analysis. According to the press release, commercial tests analyze only about 350 genes compared to MI-ONCOSEQ’s ability to cover at least 1,700 genes.
Mesothelioma is an incurable, asbestos-caused cancer of the membranes that surround many of the body’s vital organs, including the lungs. The cancer is highly aggressive and is resistant to many cancer treatments making it a difficult disease to treat effectively. Thus, developing a treatment protocol that specifically targets the genetic makeup of the patient’s cancer is vital for improving survival rates.
Mesothelioma Patients Should Heed FDA Warnings Regarding Miracle Cures
In pursuit of its mission to protect the public health by ensuring the safety and efficacy of drugs, the U.S. Food and Drug Administration sent out warning letters to 14 companies claiming their products can prevent, diagnose, treat or cure cancer. The products, none of which have been approved by the FDA, can be appealing to mesothelioma patients or anyone fighting a terminal cancer, but they could lead to severe illness or, potentially, death.
In each of the 14 letters, found on the FDA’s website, the Agency notes that the items being marketed fall under the Federal Food, Drug, and Cosmetic Act due to the intended use in the cure, mitigation, treatment, or prevention of disease. The letters go on to itemize examples of the claims on the company’s website, product label, social media and other media that provide evidence the products are intended for use as drugs.
It is a violation of federal law to market and sell products that claim to prevent, diagnose, treat, mitigate or cure diseases without first demonstrating to the FDA that they are safe and effective for their labeled uses.
Among the 65 products the FDA cited are claims for a tea with “cancer killing properties”; a vitamin that can “stop cancer cells from multiplying, kill cancer cells, and block their blood supply”; and drugs that are a “chemopreventive agent due to their ability to modulate underlying mechanisms involved in carcinogenesis.”
“Consumers should not use these or similar unproven products because they may be unsafe and could prevent a person from seeking an appropriate and potentially life-saving cancer diagnosis or treatment,” said Douglas W. Stearn, director of the Office of Enforcement and Import Operations in the FDA’s Office of Regulatory Affairs, in the April 25 press release announcing the warnings.
Although there are the rare cases of individuals who have survived mesothelioma through holistic care, the saying “it takes a village” is applicable to the fight against mesothelioma. A mesothelioma care team may include the family physician, a medical oncologist, pulmonologist, surgeon, radiologist, nurses, pathologists, nutritionists, rehab therapists and social workers.
Mesothelioma is caused by the inhalation or ingestion of airborne asbestos fibers. In the case of pleural mesothelioma, the fibers lodge deep in tissue surrounding the lungs, causing inflammation that festers for years. Chronic, persistent inflammation is a known cause of cancer, and in the case of mesothelioma, can take decades to develop into a malignancy. Mesothelioma is deemed an incurable cancer, with an estimated survival of less than 18 months after diagnosis.
Many mesothelioma patients turn to holistic treatments as complementary treatments to help relieve symptoms and to ease stress, but anytime a company makes a claim that its product can cure cancer, you can be sure the claim is fraudulent.
“We encourage people to remain vigilant whether online or in a store, and avoid purchasing products marketed to treat cancer without any proof they will work,” said Stearn. “Patients should consult a health care professional about proper prevention, diagnosis and treatment of cancer.”
The companies have 15 days from receipt of the letter to respond to the FDA with information regarding the actions they have taken to correct the violations and to assure violations do not happen again. According to the FDA, failure to correct the violations promptly may result in legal action, including product seizure, injunction and/or criminal prosecution.
Mesothelioma Patients Can See Improved Survival By Reporting Side Effects
Chemotherapy and other treatments for mesothelioma can lead to debilitating side effects such as pain, nausea and fatigue. But patients often suffer in silence with their symptoms which, when left untreated, can lead to severe complications, and even death. Now, researchers say it does not need to be that way, and, in fact, by opening up to their physicians, patients can improve their quality of life and their survival.
Researchers from Memorial Sloan Kettering Cancer Center followed 766 advanced cancer patients undergoing care at the Center, according to a June 4 report from ABC News (https://abcnews.go.com/Politics/wireStory/emergency-bill-fund-veterans-affairs-department-32742493). Hoping to catch issues before they became severe, researchers gave some of the patients access to an online tool to report to their medical team weekly, or more often if they experienced unusual or severe symptoms. The patients self-reported information on 12 common symptoms including appetite loss, diarrhea, shortness of breath, fatigue and pain.
After just six months, the patients in the online reporting group had an improved health-related quality of life and fewer trips to the emergency room. In addition, overall, they stuck with the chemotherapy treatment two months longer, eight months as opposed to six months in the non-online group.
Surprising even the researchers, median survival of the patients in the online group was nearly six months longer at 31 months versus 26 months for the control group. Researchers believe the survival was tied to early responsiveness to patients’ symptoms that prevented “adverse downstream consequences” and increased tolerance to chemotherapy allowing them to continue on the treatment beyond usual care.
“I was floored by the results,” said the study lead, Dr. Ethan Basch, a researcher at the University of North Carolina-Chapel Hill and Memorial Sloan Kettering Cancer Center in New York. “We are proactively catching things early.”
When a patient reported a concerning health issue, a nurse responded immediately almost 80 percent of the time. They would get the patient prescription medications, or appropriate care, to handle their specific issues. The tool gave the patients an easy way to report issues without struggling to get through to their doctor or wait for their next appointment.
The researchers concluded, “Electronic patient-reported symptom monitoring may be considered for implementation as a part of high-quality cancer care.” They now plan to launch a larger study to test the online reporting system nationwide.
Mesothelioma is diagnosed in approximately 3,000 Americans each year. Although treatments increase survival, countless mesothelioma patients have said the treatment is worse than the disease. That is not necessarily the case, and patients should not hesitate to reach out to their medical team to help alleviate some of their side effects.
Results of the study were presented at the 2017 ASCO Annual Meeting in Chicago. Find the full study in the June 4 issue of Journal of the American Medical Association (http://jamanetwork.com/journals/jama/fullarticle/2630810).
Mesothelioma Patients May Have Another Treatment Option With FDA Expanded-Use Approval of Lung Cancer Drug
In September, MesotheliomaHelp reported that Italian researchers found the response to ceritinib (Zykadia), an anti-cancer drug, was nearly immediate in non-small cell lung cancer patients who were previously treated with chemotherapy and crizotinib (Xalkori). Now, the U.S. Food and Drug Administration has granted approval for expanded use of the drug to include the first-line treatment of NSCLC patients with ALK-positive tumors, opening the door for another treatment option for mesothelioma patients.
Ceritinib, marketed as Zykadia by Novartis, is intended for the treatment of metastatic NSCLC in patients who express the abnormal anaplastic lymphoma kinase (ALK) gene. Approximately 3%-5% of people with NSCLC may test positive for the ALK fusion gene. There is a potential that the marker is also present in certain pleural mesothelioma cases making it a new treatment option for the cancer.
In a May 26 press release from Novartis, the company reports that of the 376 patients in the study, those receiving Zykadia as first-line treatment realized a 16.6 month progression-free survival versus 8.1 months in patients treated with pemetrexed-platinum chemotherapy first-line regimen.
“Today’s approval represents the next step in the development of Zykadia as a treatment option for ALK-positive metastatic NSCLC, bringing this important medication to a patient population where a need still exists,” said Bruno Strigini, CEO, Novartis Oncology.
Pleural mesothelioma patients and oncologists keep a close eye on research and breakthroughs that impact NSCLC patients. Although the two cancers have some differences, including the structure of the tumors, patients often follow a similar treatment protocol.
“At Novartis, we are tireless in our pursuit of developing novel medicines to treat lung cancer, and the first-line approval of Zykadia for ALK-positive metastatic NSCLC illustrates our commitment to cancer patients,” said Strigini.
Close to 3,000 patients are diagnosed with mesothelioma each year in the U.S. Although survival has improved in recent years, there is still no cure for the asbestos-caused cancer.
To find out if you may be a candidate for Zykadia, talk to your medical professional. Visit the Novartis website for more information.
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