A promising new treatment for some people with pancreatic cancer — which is notoriously difficult to detect and treat — has just moved a step closer to becoming a reality.
The drug, a type of PARP inhibitor, could reduce the risk of disease progression by a dramatic 47%. The treatment was approved for what’s called “maintenance therapy,” which means keeping the cancer from worsening after it’s been treated with chemotherapy.
Read More#FDAODAC votes 7-5 in favor of this morning’s question: “Is the risk-benefit assessment for olaparib as a maintenance therapy in patients with gBRCAm pancreatic cancer favorable?” Tune in to https://t.co/K4AgmhzjTB
FDA Oncology (@FDAOncology) December 17, 2019
“[The approval] represents a new era of the development of precision medicine in a very difficult-to-treat disease." Dr. Diane Simeone, head of pancreatic cancer at NYU Langone's Perlmutter Cancer Center, tells SurvivorNet about the news.
If approved (which is likely to occur, since the FDA usually acts according to the committee votes), Lynparza would present a much-needed option for patients with pancreatic cancers that have mutations of the BRCA gene.
It’s estimated that pancreatic cancer will take 45,750 lives in the U.S. this year alone. It took the life of actors Patrick Swayze and Alan Rickman, and currently, beloved “Jeopardy!” host Alex Trebek is undergoing treatment for the disease. It’s unknown whether this new drug approval would benefit Trebek, as the specifics of his pancreatic cancer are unknown.
The vote for approval is based on the results of a major clinical trial called POLO, which found that the addition of Lynparza after a patient already received chemotherapy decreased the likelihood of the cancer coming back by 47%. On average, patients enrolled in the clinical trial who were treated with Lynparza lived an average of four months longer without their pancreatic cancer getting any worse (a measure called “progression-free survival) than the placebo group did.
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The Importance of Genetic Testing
Because the new approval would specifically be for patients whose pancreatic cancer tumors have BRCA mutations, it’s important for people with pancreatic cancer to talk to their oncologists about getting genetic testing done as soon as the initial diagnosis.
“[This approval] highlights the fact that all our pancreatic cancer patients should undergo germline testing for cancer susceptibility genes,” Dr. Simeone says.
This need for genetic testing has been emphasized in recent years for breast cancer and ovarian cancer (both of which can benefit from this same type of PARP inhibitor drug).
PARP Inhibitors Have Changes the Game for Other Types of Cancers, Too
Important Considerations for PARP Inhibitors and Pancreatic Cancer
The FDA vote to approve Lynparza for pancreatic cancer was a close one. That’s because some doctors are arguing against approving a drug based on progression-free survival (a cancer not getting any worse) alone. The best measure for drug approvals, they say, is overall survival (the amount of time that someone lives overall), and the POLO study did not prove that the PARP inhibitor drug had an overall survival benefit.
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Another concern about the drug was the side effect profile; according to the results of the POLO trial, the chance of experiencing side effects was much higher for those given Lynzpara (40%) than it was for those who were just treated with chemotherapy alone (20%). The severity depends on the individual and the cancer, but often, the side effects for PARP inhibitors include anemia, gastrointestinal discomfort like nausea and vomiting, and fatigue.
RELATED: What Are The Side Effects of PARP Inhibitors?
But the panelists in favor of the drug won out, in part, because pancreatic cancer is a disease with so few treatment options.
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