Ovarian Cancer Drug Receives FDA
Approval
There is some good news
for ovarian cancer sufferers, as a new drug has received approval from the Food
& Drug Administration. The FDA announced it had approved olaparib on
Friday, which is for those where the BRCA gene is defective and are in late
stages of the female cancer. It will be marketed with the name Lynparza, which
is the commercial name for it.
In preliminary clinical
trials, ovarian tumors were found to have shrunk and in some cases been
eliminated all together. However, it was only found in women who had the
specific gene BRCA not working as expected and when women had been through
three or more chemotherapy treatments.
The FDA chose to give the
ovarian cancer drug accelerated approval due to the results. The response rate
and response data duration were positive enough to push for Astra-Zeneca to get
the drug out there for patients. Experts suspect that about a third of women
who have that genetic mutation will see their tumors disappear or shrink within
eight months.
A companion diagnostic has
also been given marketing approval by the administration. This will help women
identify when they have ovarian cancer in the later stages and determine who
likely the drug will work on them. It is called the BRACAnalysis CDx, created
by Myriad Genetic Inc. Only patients who take this test will be considered for
the new medication, and they must show that they are positive for the mutation.
The BRCA mutation is linked to ovarian and breast cancer, both mainly female
cancers.
Dr. Richard Pazdur, the
director of the Center for Drug Evaluation and Research’s Office of Hematology
and Oncology Products, said that the approval of the ovarian cancer medication
has brought in a “new class of drugs” and is just the first of them. It is all
due to understanding the disease more, especially the “underlying mechanisms.”
It helps to create treatments that are not just targeted but personalized.
The new drug works by
blocking the actions of a specific enzyme that tries to repair mutated DNA.
This can help to kill off the cells, especially when it comes to mutations in
the BRCA1 and BRCA2 genes. It works very differently to the way that
chemotherapy works, and will hopefully offer a better form of treatment. The
aim is to attack cancer’s weaknesses, rather than battle against it after the
fact.
Investigator for the
trial, sponsored by Astra-Zeneca, Dr. M. William Audeh, said that the drug has
led to a number of patients being in remission for the long-term. It is
something that is not seen that often when it comes to chemotherapy treatments.
There are other drugs that work in a similar way to Lynparza being created and
tested. While many are focused on the BRCA mutation, there are some that may
develop for other mutations.
The decision to approve
the medication is certainly positive. It means that further work in the area
can continue. This could also help fight against other types of cancers in the
future. So far, just the one ovarian cancer drug has received approval from the
FDA, but more may follow in the near future.
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