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Association details:
| Biomarker: | No biomarker |
|---|---|
| Cancer: | Prostate Cancer |
| Drug: | Lynparza (olaparib) (PARP inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
LYNPARZA (OLAPARIB) APPROVED IN THE UK AS COMBINATION THERAPY FOR TREATMENT OF METASTATIC CASTRATION-RESISTANT PROSTATE CANCER WHEN CHEMOTHERAPY IS NOT CLINICALLY INDICATED
Published date:
03/21/2023
Excerpt:
AstraZeneca and MSD...announced that the Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation for olaparib in the United Kingdom for use as combination therapy with abiraterone and prednisone or prednisolone, for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) in whom chemotherapy is not clinically indicated.
Secondary therapy:
abiraterone acetate;
Source:
Title:
LYNPARZA® (olaparib) in Combination With Abiraterone and Prednisone or Prednisolone Approved in the EU as Treatment for Certain Patients With Metastatic Castration-Resistant Prostate Cancer
Published date:
12/21/2022
Excerpt:
AstraZeneca and Merck...announced that LYNPARZA has been approved in the European Union (EU) in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) in whom chemotherapy is not clinically indicated.
Secondary therapy:
; abiraterone acetate
Title:
NICE recommends combination therapy for prostate cancer
Published date:
12/21/2023
Excerpt:
NICE recommends combination therapy for prostate cancer Lynparza (olaparib), which is being co-developed by AstraZeneca and MSD, showed clinically meaningful benefit when used with abiraterone and prednisone or prednisolone to treat hormone-relapsed metastatic prostate cancer. NICE recommends combination therapy for prostate cancer. The UK’s National Institute for Health and Care Excellence (NICE) has issued Final Draft Guidance recommending Lynparza (olaparib) for use as combination therapy with abiraterone and prednisone or prednisolone, for untreated hormone-relapsed metastatic prostate cancer in adults who cannot have or do not want chemotherapy.
Secondary therapy:
; abiraterone acetate
Source:
Title:
Final overall survival (OS) in PROpel: abiraterone (abi) and olaparib (ola) versus abiraterone and placebo (pbo) as first-line (1L) therapy for metastatic castration-resistant prostate cancer (mCRPC).
Published date:
02/13/2023
Excerpt:
There was a consistent trend toward OS benefit in the intention-to-treat (ITT) population with abi + ola vs abi + pbo (maturity 47.9%, HR 0.81, 95% CI 0.67–1.00, P= 0.0544), with median OS 42.1 months (m) vs 34.7 m, respectively….At the prespecified final analysis in PROpel, abi + ola prolonged OS by > 7 m vs standard-of-care abiraterone (abi + pbo) in the ITT population. The median OS of > 42 m is the longest median reported to date in a phase 3 trial in 1L mCRPC.
Secondary therapy:
abiraterone acetate
DOI:
10.1200/JCO.2023.41.6_suppl.LBA16
Trial ID:
Source:
Title:
Lynparza in combination with abiraterone recommended for approval in the EU by CHMP as 1st-line treatment for patients with metastatic castration-resistant prostate cancer
Published date:
11/14/2022
Excerpt:
AstraZeneca and MSD’s Lynparza (olaparib) in combination with abiraterone and prednisone or prednisolone has been recommended for marketing authorisation in the European Union (EU) for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) for whom chemotherapy is not clinically indicated....The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency based its positive opinion on results from the PROpel Phase III trial...
Secondary therapy:
abiraterone acetate
Source:
Title:
Lynparza in combination with abiraterone granted Priority Review in the US for patients with metastatic castration-resistant prostate cancer
Published date:
08/16/2022
Excerpt:
AstraZeneca’s supplemental New Drug Application (sNDA) for Lynparza (olaparib) in combination with abiraterone and prednisone or prednisolone has been accepted and granted Priority Review in the US for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC).
Secondary therapy:
abiraterone acetate;
Source:
Title:
Abiraterone and Olaparib for Metastatic Castration-Resistant Prostate Cancer
Published date:
06/03/2022
Excerpt:
We conducted a double-blind, phase 3 trial of abiraterone and olaparib versus abiraterone and placebo in patients with mCRPC in the first-line setting....At primary analysis at this first data cutoff, abiraterone combined with olaparib significantly prolonged ibPFS compared with abiraterone and placebo as first-line treatment for patients with mCRPC enrolled irrespective of HRRm status.
Secondary therapy:
abiraterone acetate
DOI:
https://doi.org/10.1056/EVIDoa2200043
Trial ID:
Source:
Title:
LYNPARZA® (olaparib) in Combination With Abiraterone Significantly Delayed Disease Progression in Patients Regardless of Biomarker Status in PROpel Phase 3 Trial in First-Line Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Published date:
09/24/2021
Excerpt:
AstraZeneca and Merck known as MSD outside the United States and Canada, today announced positive results from the Phase 3 PROpel trial, in which LYNPARZA in combination with abiraterone and prednisone demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of radiographic progression-free survival (rPFS) versus abiraterone plus prednisone as a first-line treatment for men with metastatic castration-resistant prostate cancer (mCRPC) with or without homologous recombination repair (HRR) gene mutations.
Trial ID:
