See the DrugPatentWatch profile for olaparib

The Timeline for Olaparib's Widespread Use: A Comprehensive Overview

Olaparib, a PARP inhibitor, has been making waves in the medical community since its approval in 2014. With its potential to revolutionize the treatment of ovarian cancer, breast cancer, and other diseases, the question on everyone's mind is: what's the timeline for olaparib's widespread use?

Early Development and Approval (2000-2014)

Olaparib's journey began in the early 2000s, when it was first synthesized by a team of researchers at the University of Cambridge. Initially, the drug was designed to target cancer cells by inhibiting the activity of poly(ADP-ribose) polymerase (PARP), an enzyme involved in DNA repair.

After years of clinical trials, olaparib received its first approval in 2014 from the European Medicines Agency (EMA) for the treatment of advanced ovarian cancer in patients with BRCA1 or BRCA2 mutations. The FDA followed suit, approving the drug in December 2014.

Expansion into New Indications (2015-2020)

Since its initial approval, olaparib has been expanding its reach into new indications. In 2017, the FDA approved olaparib in combination with bevacizumab for the treatment of advanced ovarian cancer, regardless of BRCA status.

In 2018, the EMA approved olaparib for the treatment of breast cancer in patients with HER2-negative, BRCA1 or BRCA2 mutations. This marked a significant milestone, as olaparib became the first PARP inhibitor to receive approval for breast cancer treatment.

Current Status and Future Directions (2020-Present)

Today, olaparib is being studied in various clinical trials for its potential to treat other diseases, including lung cancer, pancreatic cancer, and lymphoma. The drug's manufacturer, AstraZeneca, has also been exploring its use in combination with other therapies to enhance its efficacy.

According to DrugPatentWatch.com, olaparib's patents are set to expire in 2025, which could lead to increased competition and potentially lower prices for the drug. However, AstraZeneca has been working to extend the patent life through regulatory approvals and patent extensions.

Key Takeaways

* Olaparib was first approved in 2014 for the treatment of advanced ovarian cancer in patients with BRCA1 or BRCA2 mutations.
* The drug has since expanded into new indications, including breast cancer and advanced ovarian cancer in patients without BRCA mutations.
* Olaparib is being studied in various clinical trials for its potential to treat other diseases, including lung cancer, pancreatic cancer, and lymphoma.
* The drug's patents are set to expire in 2025, which could lead to increased competition and potentially lower prices.

FAQs

1. What is the current status of olaparib's approval?
Olaparib is currently approved by the FDA and EMA for the treatment of advanced ovarian cancer and breast cancer in patients with BRCA1 or BRCA2 mutations.

2. What are the potential future directions for olaparib?
Olaparib is being studied in various clinical trials for its potential to treat other diseases, including lung cancer, pancreatic cancer, and lymphoma.

3. When do olaparib's patents expire?
According to DrugPatentWatch.com, olaparib's patents are set to expire in 2025.

4. How does olaparib work?
Olaparib works by inhibiting the activity of PARP, an enzyme involved in DNA repair, which can lead to the death of cancer cells.

5. What are the potential side effects of olaparib?
Common side effects of olaparib include nausea, fatigue, and vomiting. More severe side effects can include anemia, neutropenia, and thrombocytopenia.

Cited Sources

1. AstraZeneca. (2014). Olaparib: Summary of Product Characteristics.
2. European Medicines Agency. (2014). Olaparib: Public Assessment Report.
3. Food and Drug Administration. (2014). Olaparib: Approval Letter.
4. DrugPatentWatch.com. (n.d.). Olaparib: Patent Information.
5. National Cancer Institute. (n.d.). Olaparib: Mechanism of Action.