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NICE publish draft approval documents for the use of olaparib (Lynparza) in the treatment of ovarian, fallopian tube and peritoneal cancer

Lynparza▼, for Ovarian cancer, Fallopian tube cancer and Peritoneal cancer from AstraZeneca

The National Institute for Health and Care Excellence (NICE) are to recommend use of AstraZeneca's cancer treatment olaparib, brand name Lynparza.

The approval is for use of Lynparza for maintenance treatment of ovarian, fallopian tube or peritoneal cancer in patients that have an inherited mutation of their BRCA genes. This means that patients in England will be able to be treated with Lynparza if they meet the conditions and their doctor thinks it appropriate.

BRCA1 and BRCA2 are human genes that produce tumour suppressor proteins. These proteins help repair damaged DNA and, therefore, play a role in ensuring the stability of each cell’s genetic material. Mutations can result in a greater likelihood of the cells becoming cancerous. 

Lynparza can be used if patients respond to another treatment called first-line platinum-based chemotherapy.

NICE state that there are currently no maintenance treatments for patients with these cancers and the approval of Lynparza is based on the results of clinical trials.

Lynparza is to be funded under the Cancer Drugs Fund for these conditions and will be available as an option for patients in England under the NHS.

NICE have agreed a price for the treatment with the manufacturers.

You can follow developments with Lynparza by using our Medicines Tracker service which provides users with updates about the medicines they are interested in.

Why the NICE made these recommendations
There are currently no maintenance treatments for BRCA mutation positive (a gene mutation in the patients cells) advanced ovarian, fallopian tube or peritoneal cancer after a positive response to first-line platinum-based chemotherapy.

Lynparza (olaparib) is currently recommended after 3 or more lines of platinum-based chemotherapy. Using olaparib earlier in the treatment pathway would be an important development because earlier use can achieve the greatest
benefit and may have the potential to cure the disease.

An ongoing clinical trial shows that olaparib delays disease progression. But it is not known whether people having olaparib live longer, because people in the trial have not been followed-up for long enough. The currently available clinical trial evidence does not show a significant difference in overall survival between olaparib and placebo. This makes the estimates of cost effectiveness very uncertain. Therefore, olaparib is not recommended for routine use in the NHS.

If olaparib increases the length of time people live it has the potential to be cost effective, but more evidence from the ongoing trial is needed to address the uncertainties. Therefore it is recommended for use in the Cancer Drugs Fund, while further data are collected.

About Lynparza (source EMA)
Lynparza is a cancer medicine used on its own for:
  • continuing treatment of high-grade (fast-growing) cancers of the ovaries, fallopian tubes (which connect the ovaries to the womb) and the peritoneum (membrane lining the abdomen) in:
  • women whose cancer had come back (relapsed) after previous treatment and in whom platinum-based chemotherapy has reduced or cleared the cancer;
  • in newly diagnosed women with advanced cancer with mutations (changes) in one or both genes known as BRCA1 and BRCA2 who have been treated with platinum-based chemotherapy and in whom this treatment has reduced or cleared the cancer;
  • treatment of breast cancer which is HER2-negative and that has spread beyond the original site in patients with mutations in BRCA1 or BRCA2 genes who have been treated with certain breast cancer medicines (unless these medicines were not suitable).
The active substance in Lynparza, olaparib, blocks the action of enzymes which help to repair damaged DNA in cells (both in normal and in cancer cells) during cell division. Therefore, when the proteins are blocked, the damaged DNA in cancer cells cannot be repaired, and, as a result, the cancer cells die.

Lynparza was first made available in the EU in 2014. It is manufactured by AstraZeneca.

Sources
European Medicines Agency website page for Lynparza
National Cancer Institute (US)
Accessed 27/07/19
Links available in full article

© NICE [2019]

Olaparib for maintenance treatment of ovarian, fallopian tube or peritoneal cancer that has a BRCA mutation after response to first-line platinum-based chemotherapy [ID1124]. In development [GID-TA10257]. Expected publication date: 28 August 2019
Available from: See Link below. All rights reserved. Subject to Notice of rights
NICE guidance is prepared for the National Health Service in England. All NICE guidance is subject to regular review and may be updated or withdrawn. NICE accepts no responsibility for the use of its content in this product/publication.

The information provided by NICE was accurate at the time this article was issued.


NICE information on Lynparza

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