Lynparza (olaparib) is a targeted therapy for treating cancer, including ovarian cancer. It is only available through a prescription and can have several side effects.

Ovarian cancer occurs when cells in the ovaries or fallopian tubes grow uncontrollably.

Some people refer to Lynparza as a poly ADP-ribose polymerase (PARP) inhibitor.

Health professionals may prescribe Lynparza as maintenance or active treatment. Maintenance treatments help prevent cancer cells from returning after chemotherapy, while active treatments focus on shrinking or slowing the growth of cancer.

This article will explore Lynparza’s suitability as a treatment, the clinical trial approval process, how healthcare professionals prescribe it, and the possible side effects of this therapy.

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Lynparza works by targeting PARP, an enzyme in the body that supports the repair of damaged cells, including cancer cells. The therapy inhibits PARP and stops the repair of cancerous cells to prevent them from growing.

Lynparza is suitable for cancers with a BRCA gene mutation, such as the BRCA1 and BRCA2 genes, which produce proteins that aid in DNA repair. Sometimes, mutations in these genes increase the risk of developing cancers, including ovarian and breast cancer.

A person can also inherit a mutated form of the BRCA genes from their biological parents.

Lynparza currently has approval from the Food and Drug Administration (FDA) for:

  • first-line maintenance treatment of BRCA-mutated advanced ovarian cancer
  • first-line maintenance treatment of homologous recombination deficiency-positive advanced ovarian cancer in combination with bevacizumab
  • maintenance treatment of recurrent ovarian cancer
  • advanced BRCA-mutated ovarian cancer after three or more lines of chemotherapy

Lynparza also has approval for use in the active treatment of BRCA-mutated metastatic breast cancer and the maintenance treatment of BRCA-mutated metastatic pancreatic cancer.

Pharmaceutical companies undergo a stringent approval process before they can sell their products to the public. In the United States, the FDA grants or denies the sale of drugs by pharmaceutical companies.

Within the FDA, the Center for Drug Evaluation and Research evaluates new drugs before they reach the market.

The drug manufacturer develops the drug and tests it on animals to check its toxicity. After this, the manufacturer makes an application to the FDA with a plan to test the drug on humans. This application is an Investigational New Drug (IND) application.

After review and approval of the IND application by the FDA, the drug manufacturer can begin clinical trials, which involve testing the drug on humans. The researchers design the clinical trials to answer specific questions about the drug.

There are distinct clinical trial phases. These include:

Phase 1

Phase 1 trials normally comprise 20–80 healthy volunteers and can take several months. It aims to analyze the safety of the drug, possible side effects, and how the body metabolizes and removes it. The FDA states that approximately 70% of drugs move to the next phase.

Phase 2

This phase can include several hundred people with the condition or disease that the drug aims to treat. It can last from several months to 2 years, and it seeks to investigate the effectiveness of the drug and its side effects. The FDA says that around 33% of drugs move on to the next phase.

Phase 3

This phase will normally comprise between 300 and 3,000 volunteers with the disease or condition of interest. This phase can last between 1 and 4 years, and its purpose is to investigate the drug’s effectiveness and side effects. The FDA estimates that about 25–30% of drugs move on to the next phase.

Phase 4

Phase 4 comprises several thousand volunteers with the disease or condition of interest. This phase occurs after the drug enters the market, and its purpose is to investigate the safety and efficacy of the drug in a real-life setting.

Additionally, some drugs may obtain accelerated approval, where a drug receives early approval because it treats serious diseases and conditions more effectively than existing therapies.

The FDA granted Lynparza accelerated approval for the treatment of advanced ovarian cancer in patients with BRCA-mutations.

A diagnostic companion device is a medical device that can obtain information about the effectiveness and safety of a drug.

Health professionals can use this data to determine whether a person would benefit from a particular drug or therapy. It also helps them decide whether the drug’s benefits outweigh the potential side effects.

Currently, the FDA approves the diagnostic companion device, BRACAnalysis CDx, for use with Lynparza in the treatment of:

BRACAnalysis CDx identifies patients with BRCA1 and BRCA2 mutations. It can detect variants in the protein-coding region of the BRCA1 and BRCA2 genes from a person’s blood sample.

Other diagnostic companion devices that the FDA approves for use with Lynparza include FoundationOneCDx for ovarian cancer and metastatic castrate-resistant prostate cancer and Myriad myChoice CDx for ovarian cancer.

Health professionals may prescribe Lynparza as an active or maintenance treatment.

Lynparza is available in capsules and tablets, with the latter available in 150-milligram (mg) and 100-mg dosages.

The FDA recommends a 300 mg dose of Lynparza twice a day with or without food. A health professional may modify the amount for certain people, such as individuals with kidney problems or who are taking other medication.

A person taking Lynparza should swallow the tablets whole without chewing, crushing, or dividing them. If they miss a dose, they should take their next dose at the scheduled time and never double the dose.

Some people may experience side effects with Lynparza treatment. The most common side effects include:

Some rarer but more serious side effects include:

A person using Lynparza should consult a doctor if they experience any of the side effects above. People should also speak with their doctor if they have missed a dose or taken more than the recommended dosage.

Anyone who wishes to receive Lynparza treatment should consult a health professional to see if they are suitable.

Lynparza is a targeted therapy to treat certain cancers, such as ovarian cancer and breast cancer.

Health professionals may prescribe Lynparza as an active treatment to shrink or slow cancer growth or maintenance treatment to prevent cancer from returning. Lynparza targets the enzyme PARP to prevent it from repairing damaged DNA.

Side effects of Lynparza include fatigue, vomiting, and diarrhea, while more serious side effects include acute myeloid leukemia and pneumonitis.

A person should speak with a doctor if they experience side effects from Lynparza.