Ovarian Cancer Drug Receives FDA Approval

Ovarian cancer

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.

By Alexandria Ingham



L.A. Times

Wall Street Journal

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