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Update: New FDA approval of PARP inhibitor for maintenance therapy in ovarian cancer

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Contents

At a glance Clinical trials
What is ?   Guidelines              
What is first-line treatment? Questions for your doctor 
What does this mean for me? Resources


APPROVAL AT A GLANCE

This update is about: 

On April 29, 2020, the U.S. Food and Drug Administration approved , () as a first-line for women with advanced ovarian cancer who have had a complete or partial response to chemotherapy. is a type of known as a . This approval applies to women both with, and women without a mutation.


What is ?

 is a type of treatment that is given after chemotherapy treatment has been completed to try to keep the cancer from returning. The goal of  is to extend the length of time before a new recurrence emerges or even to turn a temporary remission into a long-term cure. Two types of agents—PARP inhibitors and bevacizumab—have been  approved for use as  in women with advanced ovarian, and primary peritoneal cancer. 


What is first-line treatment?

First-line treatment or therapy is the first treatment given for a disease such as cancer. Second-line treatments are used if the cancer doesn’t respond to first-line treatment or the cancer returns.  

After a woman has been diagnosed with ovarian cancer, first-line treatment is usually several months of chemotherapy. If her cancer responds well to treatment, she may stop treatment or begin , unless her cancer comes back. If her cancer comes back, she will receive second-line treatment which maybe a new course of chemotherapy or another type of treatment. If her cancer does not respond, or comes back again, the following treatment would be called third-line. 


Why is this approval important?

Treatment of ovarian cancer remains a challenge. Most ovarian cancers respond well to chemotherapy; however, the majority will recur within five years. Until now, PARP inhibitors were only approved for the following situations:

  • As treatment for recurrent advanced ovarian cancer in women with a or mutation (found through genetic testing or tumor testing) who have received two or more previous lines of treatment
  • As for women with a or who have completed first-line (or higher) chemotherapy
  • As for women without a or mutation who completed at least second-line (or higher) chemotherapy.  

This is the first approval that allows women with advanced ovarian cancer without a mutation to use a as after first-line treatment.


Research findings:

approval of was based on previous research from the PRIMA trial, which we reported in this XRAY review.

PRIMA looked at whether was safe and effective as after a response to chemotherapy (before recurrence) in women with newly diagnosed ovarian cancer:

  • Women who received after completing chemotherapy survived longer without their cancer coming back than women who received after completing chemotherapy. This is known as progression-free survival. Women who received as after completing treatment:
    • had an average progression-free survival time of almost 14 months compared to 8 months for patients who received a after completing treatment.
    • had an overall survival rate after two years rate of 84 percent, compared to 77 percent for patients who received a .
  • caused severe, but not life-threatening side effects in 65 percent of patients enrolled in the study. The most common side effects seen with include:
    • low blood counts (e.g., anemia, low platelet count and low white blood cell count)
    • nausea
    • constipation
    • fatigue
    • headache
    • insomnia
    • vomiting
    • abdominal pain

Low blood cell counts were managed by reducing the dose of or taking a break from treatment.


What does this mean for me?

If you have been diagnosed with advanced ovarian cancer and you have had a complete or partial response to chemotherapy, you may want to talk to your doctor about  with or another .

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Posted 5/7/20

Reference

approves for first-line maintenance of advanced ovarian cancer.


Disclosure

FORCE receives funding from industry sponsors, including companies that manufacture cancer drugs, tests and devices. All XRAYS articles are written independently of any sponsor and are reviewed by members of our Scientific Advisory Board prior to publication to assure scientific integrity.

This article is relevant for:

People with advanced ovarian cancer who have had a complete or partial response to chemotherapy

This article is also relevant for:

People with platinum-sensitive ovarian cancer

Women under 45

Women over 45

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Expert Guidelines
Expert Guidelines

The following NCCN recommendations are for for women with ovarian cancer who have had a complete or partial response to first-line therapy:

  • Women who have a mutation may benefit from a as .
  • Women who have a mutation and had Avastin as part of their first-line treatment may benefit from a alone or Lynparza and Avastin as .
  • Women who do not have a mutation and had Avastin as part of their first-line treatment may benefit from a alone or in combination with Avastin as , depending on their status.
  • Women who do not have a mutation and did not have Avastin as part of their first-line treatment may benefit from a as .

Updated: 12/07/2021

Questions To Ask Your Doctor
Questions To Ask Your Doctor

  • Is with an option for my ovarian cancer?
  • If is not an option for me right now, might it be an option in the future?
  • What side effects might I experience with this treatment?
  • If I have serious side effects, will I need to stop treatment?
  • Are any other agents available to treat my cancer?

Open Clinical Trials
Open Clinical Trials

The following are studies looking at PARP inhibitors and similar agents for treating people with ovarian cancer.  

A number of other clinical trials for people with ovarian cancer can be found here.

Updated: 03/13/2022

Open Clinical Trials
Open Clinical Trials

The following are studies looking at treatment for people with advanced

Updated: 08/23/2022

Peer Support
Peer Support

The following organizations offer peer support services for people with or at high risk for ovarian cancer:

Updated: 02/05/2022

Who covered this study?

OncLive

FDA approves Niraparib for frontline maintenance in ovarian cancer This article rates 3.5 out of 5 stars

New York Times

U.S. FDA gives broader approval to GSK's Zejula for ovarian cancer This article rates 3.0 out of 5 stars

How we rated the media

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