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olaparib

NICE fail to recommend AstraZeneca's cancer drug Olaparib on cost effectiveness basis

Britain’s cost effectiveness body the National Institute of Health and Care Excellence (NICE) has chosen not to recommend AstraZeneca’s Olaparib for women with advanced ovarian cancer who had previously responded to platinum chemotherapy for six months or longer.

AZ’s Lynparza gets prostate cancer breakthrough status

Lynparza

AstraZeneca’s Lynparza has been granted breakthrough therapy designation by the FDA as a monotherapy for the treatment of a specific group of patients with gene mutated prostate cancer.

The status applies to people with BRCA1/2 or ATM gene mutated metastatic castration-resistant prostate cancer (mCRPC), who have received a prior taxane-based chemotherapy and at least one newer hormonal agent (abiraterone or enzalutamide).

NICE recommends AstraZeneca’s Lynparza after price reduction

Lynparza
Lynparza is the first cancer drug targeted to an inherited genetic fault to be available on the NHS

NICE has recommended AstraZeneca’s Lynparza for maintenance treatment of relapsed ovarian, fallopian tube and peritoneal cancer.

In draft guidance the UK healthcare watchdog recommends Lynparza (olaparib) for cancers in people who have tested positive for the BRCA1 or BRCA2 mutations, whose disease has responded to platinum-based chemotherapy. 

NICE Lynparza rejection labelled ‘hard to understand’

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AstraZeneca has appealed to the government to put ‘urgent transitional measures’ in place to make sure patients can access innovative cancer treatments – after its ovarian cancer drug Lynparza was knocked back by NICE.

In its preliminary guidance on Lynparza (olaparib) for ovarian, fallopian tube and peritoneal cancer, the UK healthcare watchdog found that for people who have BRCA1 or BRCA2 mutations whose cancer has already responded to treatment with second-line or subsequent platinum-based chemotherapy, “the price is too high for the benefit it may provide to patients”.

AstraZeneca drops CDF application

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AstraZeneca has withdrawn its application for its drug Lynparza to be on the Cancer Drugs Fund (CDF), citing concerns with the current cost-effectiveness re-reviews of medicines on the list.

Lynparza (olaparib) was approved by the European Commission last month and is currently awaiting review by NICE, but the UK company was looking to get it on the CDF list in order to get it to market sooner.

However, AZ says it believes Lynparza would be ‘caught up’ in the current process of re-reviews affecting drugs already on the list.

AstraZeneca ovarian cancer drug approved in Europe

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The European Commission has approved AstraZeneca’s Lynparza for the treatment of advanced BRCA-mutated ovarian cancer.

Lynparza (olaparib) has been approved for use with patients who are in complete or partial response to chemotherapy and to treat adult patients with relapsed ovarian, fallopian tube, or primary peritoneal cancers.

“We are delighted to be able to bring this much needed treatment to patients with BRCA-mutated ovarian cancer whose options are currently very limited.

AZ oncology drug a 'Phoenix from the flames’

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As the possibility of a deal with Pfizer fades, AstraZeneca is continuing its argument for independence as a key cancer drug is recommended for use in Europe.

The CHMP has said that Lynparza (olaparib) should be used on the continent as monotherapy for the maintenance treatment of adult patients with platinum sensitive relapsed BRCA-mutated high grade serous epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy.

FDA rejects olaparib

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AstraZeneca has been dealt a blow by a key advisory committee to the US Food and Drug Administration, which has voted not to approve investigational medicine olaparib.

The drug is a potential first-in-class oral poly ADP ribose polymerase (PARP) inhibitor for ovarian cancer, and had been expected to reach peak annual sales of around $1.5 billion.

AstraZeneca faces olaparib questions

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AstraZeneca is facing questions from US regulators over the efficacy of one of its most promising late-stage treatments.

Olaparib is a potential first-in-class oral poly ADP ribose polymerase (PARP) inhibitor for ovarian cancer and is expected to reach peak annual sales of around $1.5 billion.

AstraZeneca begins olaparib programme

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AstraZeneca has begun recruitment in its Phase III programme for olaparib, a potential first-in-class oral poly ADP ribose polymerase (PARP) inhibitor for patients with BRCA mutated ovarian cancer.

The SOLO programme will look at progression-free survival (PFS) in patients taking olaparib as a maintenance monotherapy when they are in complete or partial response, following platinum-based chemotherapy in the first line (SOLO 1) and relapsed (SOLO 2) settings.

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