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Lynparza secures accelerated FDA review for metastatic castration-resistant prostate cancer

Following the recommendation of the tablet formulation of the drug for use on the NHS in England and Wales, news has broken that AstraZeneca and MSD’s Lynparza (olaparib) has been accepted by the FDA in the US under Priority Review

The therapy is indicated in metastatic castration-resistant prostate cancer (mCRPC) and deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene mutations in patients who have progressed following prior treatment with a new hormonal agent.

Lynparza tablets approved for NHS use in platinum-sensitive, BRCA-mutated ovarian, fallopian tube or peritoneal cancer

It has been announced that tablet form of Lynparza (olaparib), the PARP inhibitor developed by AstraZeneca and MSD, has secured recommendation from NICE  for the treatment of relapsed platinum-sensitive ovarian, fallopian tube or peritoneal cancer in adult patients with a BRCA1 or BRCA2 mutation.

Data supplied in support of the case for the drug’s recommendation demonstrated that Lynparza presented a progression-free survival benefit of 19.1 months, compared to 5.5 months for placebo.

FDA advisory committee approves the use of Lynparza in pancreatic cancer

The FDA’s Oncologic Drugs Advisory Committee (ODAC) has recommended the approval of AstraZeneca and Merck’s Lynparza (olaparib) to treat pancreatic cancer.

The two companies are seeking approval of the drug to treat patients who show no improvement after receiving first line platinum-based chemotherapy.

The ODAC voted 7 to 5 on the decision for the use of the drug as a first-line maintenance monotherapy in individuals with germline BRCA-mutated (gBRCAm) metastatic pancreatic adenocarcinoma.

NICE authorises Lynparza for NHS use in all BRCA-mutated ovarian cancer cases

NICE has given its recommendation for the routine use on the NHS in England and Wales of AstraZeneca and MSD’s Lynparza (olaparib) for the maintenance treatment of relapsed, advanced, BRCA+ ovarian cancer, it has been announced, making the drug available to all BRCA-mutated patients.

Specifically, this new ruling affects adult NHS patients who are living with relapsed, platinum-sensitive high grade epithelial ovarian, fallopian tube or peritoneal cancer with the BRCA1 or BRCA2 mutation (BRCAm) which has responded to platinum-based chemotherapy.

Lynparza extends progression-free survival in first-line advanced ovarian cancer, with or without BRCA mutations

New Phase 3 data has emerged on AstraZeneca and MSD’s Lynparza (olaparib), showing that the PARP inhibitor achieved its primary endpoint in the first-line maintenance of advanced ovarian cancer in patients with or without BRCA mutations when added to standard-of-care bevacizumab, compared to bevacizumab alone.

The companies declared that the drug combo was found to produce a £statistically-significant and clinically-meaningful improvement in progression-free survival (PFS)”, marking the second positive set of results for Lynparza in first-line ovarian cancer.

AstraZeneca's Lynparza meets primary endpoint in Phase 3 prostate cancer trial

AstraZeneca’s PARP inhibitor Lynparza was successful in improving progression free survival in a Phase 3 trial of patients with metastatic prostate cancer.

The drug met its primary endpoint in the Phase 3 PROfound  trial of men with metastatic castration-resistant prostate cancer (mCRPC) who have a *homologous recombination repair gene mutation (HRRm) and have progressed on prior treatment with new hormonal anticancer treatments (e.g. enzalutamide and abiraterone).

AstraZeneca's Lynparza approved via Cancer Drugs Fund for BRCA+ gynaecological cancers

NICE has published final guidance which approves AstraZeneca’s Lynparza (olaparib) for use on the NHS as a maintenance therapy for advanced high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer in adult BRCA+ patients that have responded to first-line platinum-based chemotherapy.

The medicine will be made available via the Cancer Drugs Fund while additional data is harvested from an ongoing clinical trial. It was previously approved by the UK watchdog, but not until much later in the treatment pathway, in advanced ovarian cancer.

EU approval for MSD and AZ's Lynparza in first-line BRCA-mutated advanced ovarian cancer

AstraZeneca and MSD’s jointly-developed therapy Lynparza (olaparib) has scored its third EU approval, the pair announced, with authorisation for the first-line treatment of female patients with BRCA-mutated advanced ovarian cancer.

Specifically, the authorisation covers the maintenance of FIGO Stages III and IV BRCA1/2-mutated (germline and/or somatic) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer in those who are in response (complete or partial) following completion of 1st-line platinum-based chemotherapy.

AZ and MSD's Lynparza secures CHMP nod in first-line BRCA-mutated ovarian cancer

AstraZeneca and MSD’s Lynparza (olaparib) has received a positive opinion from the EMA’s Committee for Medicinal Products for Human Use (CHMP), it has emerged, as a first-line maintenance treatment of BRCA-mutated advanced ovarian cancer.

Specifically, the recommendation covers the use of the drug as a maintenance treatment for adult patients advanced BRCA1/2-mutated (germline and/or somatic) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy.

Europe approves Lynparza in HER2-, gBRCAm advanced breast cancer

Lynparza (olparib), the poly ADP ribose polymerase (PARP) inhibitor developed by AstraZeneca and MSD, has been awarded marketing approval by the European Commission, it has emerged, as a monotherapy for the treatment of human epidermal growth factor receptor 2 (HER2)-negative locally-advanced or metastatic breast cancer with germline BRCA1/2-mutations (gBRCAm).

Phase 3 data submitted in support of the application demonstrated that Lynparza improved median progression-free survival by 2.8 months and doubled objective response rates to 52% from 23% compared to physician’s choice of c

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