Lynparza (olaparib) is a targeted treatment used to treat cancer, notably ovarian cancer. It is only available with a prescription and has a number of potential negative effects.
Ovarian cancer develops when cells in the ovaries or fallopian tubes grow out of control.
Lynparza is also referred to as a poly ADP-ribose polymerase (PARP) inhibitor.
Lynparza may be prescribed by a doctor as a preventative or active treatment. Maintenance treatments work to keep cancer cells from returning after chemotherapy, whereas active treatments work to decrease or slow the growth of cancer.
The purpose of this page is to discuss Lynparza’s suitability as a treatment, the clinical trial approval procedure, how healthcare professionals prescribe it, and the potential adverse effects of this medicine.
When to consult a physician
If a person using Lynparza has any of the above-mentioned side effects, they should visit a doctor. People should also consult their doctor if they miss a dose or take more than the suggested amount.
Anyone interested in receiving Lynparza treatment should visit with a medical expert to discover if they are a candidate.
Suitability of treatment
Lynparza works by targeting PARP, a body enzyme that aids in the repair of damaged cells, including cancer cells. The medication inhibits PARP and prevents malignant cells from repairing themselves, so preventing them from proliferating.
Lynparza is indicated for cancers characterized by a BRCA gene mutation, such as the BRCA1 and BRCA2 genes, which create proteins that aid in DNA repair. Mutations in these genes can sometimes increase the chance of developing cancers such as ovarian and breast cancer.
A mutant variant of the BRCA genes can also be inherited from one’s biological parents.
Lynparza is now approved by the Food and Drug Administration (FDA) for the following indications:
- 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 has also been approved for the active treatment of BRCA-mutated metastatic breast cancer as well as the maintenance treatment of BRCA-mutated metastatic pancreatic cancer.
The clinical trial approval process
Pharmaceutical businesses must go through a rigorous approval process before they can offer their medications to the general public. In the United States, the FDA approves or prohibits pharmaceutical companies’ sales of medications.
The Center for Drug Evaluation and Research of the FDA examines new medications before they are released to the public.
The drug producer creates the medicine and tests it on animals to ensure its safety. Following that, the manufacturer applies to the FDA with a proposal to test the medicine on humans. This is an IND (Investigational New Drug) application.
The drug company can commence clinical studies, which involve testing the medicine on humans, after the FDA reviews and approves the IND application. The clinical trials are designed by the researchers to answer particular questions concerning the medicine.
There are various stages of clinical trials. These are some examples:
Phase 1
Phase 1 trials typically include 20–80 healthy volunteers and can last many months. Its goal is to investigate the drug’s safety, potential side effects, and how the body metabolizes and eliminates it. According to the FDA, around 70% of medications progress to the next level.
Phase 2
Several hundred people with the condition or disease that the medicine is intended to treat may be included in this phase. It can continue from six months to two years and aims to study the drug’s efficacy as well as its negative effects. According to the FDA, around 33% of medications progress to the next phase.
Phase 3
Typically, between 300 and 3,000 volunteers with the disease or condition of interest will participate in this phase. This phase can span between one and four years and is used to assess the drug’s efficacy and side effects. According to the FDA, approximately 25–30% of medications progress to the next phase.
Phase 4
Several thousand volunteers with the disease or condition of interest are involved in Phase 4. This phase happens after the drug is released to the market, and its objective is to evaluate the drug’s safety and efficacy in a real-world situation.
Furthermore, some pharmaceuticals may be granted accelerated approval, which occurs when a drug is granted early approval because it addresses critical diseases and conditions more successfully than existing therapies.
Lynparza was granted fast approval by the FDA for the treatment of advanced ovarian cancer in women with BRCA mutations.
Diagnostics
A diagnostic companion device is a medical gadget that can gather data on the efficacy and safety of a medicine.
This information can be used by doctors to determine whether a patient would benefit from a certain medicine or therapy. It also assists them in determining if the benefits of the drug exceed the potential negative effects.
BRACAnalysis CDx, a diagnostic companion device, is now approved by the FDA for use with Lynparza in the treatment of:
- pancreatic cancer
- metastatic castrate-resistant prostate cancer
- breast cancer
- ovarian cancer
BRACAnalysis CDx identifies BRCA1 and BRCA2 mutations in patients. From a blood sample, it can detect mutations in the protein-coding area of the BRCA1 and BRCA2 genes.
FoundationOneCDx for ovarian cancer and metastatic castrate-resistant prostate cancer, as well as Myriad myChoice CDx for ovarian cancer, are other diagnostic companion devices approved by the FDA for use with Lynparza.
How it is prescribed and used
Lynparza may be prescribed by a doctor as an active or maintenance medication.
Lynparza comes as capsules and tablets, with the latter available in 150-milligram (mg) and 100-milligram (mg) dosages.
The FDA suggests taking Lynparza 300 mg twice a day, with or without food. For specific people, such as those with kidney difficulties or who are on other medications, a health expert may adjust the quantity.
Lynparza tablets should be taken whole, without chewing, crushing, or separating them. If they miss a dose, they should take it at the next regular time and never double the dose.
Side effects
Lynparza therapy may cause negative effects in some people. The following are the most common side effects:
- low red blood cell count, or anemia
- decreased appetite
- fatigue
- nausea
- constipation
- mouth sores
- cold and flu symptoms
- vomiting
- low white blood cell count
- upper respiratory tract infections
- diarrhea
- bone and joint pain
- changes in taste
- headache
Some uncommon but serious adverse effects include:
- pneumonitis, an allergic reaction in the lungs
- venous thromboembolic events, including pulmonary embolism
- myelodysplastic syndrome, a group of blood and bone marrow cancers
- embryo-fetal toxicity in pregnant people
- acute myeloid leukemia, a blood cell cancer
Conclusion
Lynparza is a targeted medication used to treat cancers such as ovarian cancer and breast cancer.
Lynparza may be prescribed by a doctor as an active treatment to decrease or slow cancer growth, or as a maintenance medication to prevent cancer from returning. Lynparza inhibits the enzyme PARP’s ability to repair damaged DNA.
Lynparza side effects include fatigue, vomiting, and diarrhea, as well as more serious side effects such as acute myeloid leukemia and pneumonitis.
If a person experiences Lynparza side effects, they should consult a doctor.
Sources:
- https://www.accessdata.fda.gov/cdrh_docs/pdf14/p140020c.pdf
- https://www.cancer.gov/about-cancer/causes-prevention/genetics/brca-fact-sheet
- https://www.fda.gov/medical-devices/in-vitro-diagnostics/companion-diagnostics
- https://www.fda.gov/drugs/development-approval-process-drugs
- https://www.fda.gov/media/82381/download
- https://www.medicalnewstoday.com/articles/lynparza-for-the-treatment-of-ovarian-cancer
- https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208558s014lbl.pdf
- https://www.breastcancer.org/treatment/targeted_therapies/lynparza
- https://www.ncbi.nlm.nih.gov/labs/pmc/articles/PMC6096977/
- https://www.fda.gov/patients/drug-development-process/step-3-clinical-research
- https://www.cancer.org/cancer/ovarian-cancer/treating/targeted-therapy.html
- https://www.lynparza.com/what-is-lynparza.html
- https://www.cancer.org/cancer/ovarian-cancer/about/what-is-ovarian-cancer.html
