LYNPARZA (olaparib) Approved in China for the Treatment of Certain Patients with BRCA-Mutated Metastatic Castration-Resistant Prostate Cancer

Only PARP Inhibitor to Demonstrate Overall Survival Versus New Hormonal Treatments in BRCA1/2-Mutated Advanced Prostate Cancer

AstraZeneca and Merck, known as MSD outside the United States and Canada, today announced that LYNPARZA has been granted conditional approval in China as monotherapy for the treatment of adult patients with germline or somatic BRCA-mutated metastatic castration-resistant prostate cancer (mCRPC) who have progressed following prior treatment that included a new hormonal agent (abiraterone, enzalutamide).

The approval by the Chinese National Medical Products Administration was based on a subgroup analysis of the Phase 3 PROfound trial which showed that LYNPARZA demonstrated a substantial improvement in radiographic progression-free survival (rPFS) and overall survival (OS) versus abiraterone or enzalutamide in men with BRCA1/2 mutations. Continued approval is contingent upon verification and description of clinical benefit in a planned bridging trial with Chinese patients.

In China, prostate cancer is the sixth most prevalent cancer in men, with approximately 115,000 new patients diagnosed each year and about 7% have germline BRCA mutations.Prostate cancer patients with these mutations are more likely to have poorer outcomes than those without the mutations. Approximately 70% of prostate cancer patients in China have advanced disease at the time of diagnosis, and for those with mCRPC the median survival time is less than two years.

Dave Fredrickson, executive vice president, oncology business unit, AstraZeneca, said, “LYNPARZA more than tripled radiographic progression-free survival and is the only PARP inhibitor to show an overall survival benefit compared to treatment with abiraterone or enzalutamide for men with BRCA-mutated metastatic castration-resistant prostate cancer.”

Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories, said, “The approval underscores the critical importance of BRCA testing in men with prostate cancer. We are proud to provide a new personalized treatment option for men with this devastating disease in China, and we will continue to collaborate with the Chinese government and healthcare organizations to bring LYNPARZA to patients who need it.”

Results from the subgroup analysis from the PROfound trial showed LYNPARZA reduced the risk of disease progression or death by 78% (HR=0.22 [95% CI, 0.15-0.32]; p<0.0001) and improved rPFS to a median of 9.8 months versus 3.0 months with abiraterone or enzalutamide in men with mCRPC with BRCA1/2 mutations. In addition, LYNPARZA reduced the risk of death by 37% (HR=0.63 [95% CI, 0.42-0.95]) with a median OS of 20.1 months versus 14.4 months with abiraterone or enzalutamide. The primary results and OS results from the PROfound Phase 3 trial were published in The New England Journal of Medicine last year.

The most common adverse reactions (ARs) in the PROfound trial, occurring in ≥10% of subjects, for LYNPARZA compared to abiraterone or enzalutamide were anemia (46% vs.15%), nausea (41% vs. 19%), fatigue (including asthenia) (41% vs. 32%), decreased appetite (30% vs. 18%), diarrhea (21% vs. 7%), vomiting (18% vs. 12%), thrombocytopenia (12% vs. 3%), cough (11% vs. 2%) and dyspnea (10% vs. 3%). Dose interruptions due to an AR occurred in 45% of patients receiving LYNPARZA and dose reductions due to an AR occurred in 22% of LYNPARZA patients. Discontinuation due to ARs occurred in 18% of LYNPARZA patients.

Tags : #LatestPharmaNewsJune24 #LatestMerckNewsJune24 #TreatmentforCancer

Related Stories

Loading Please wait...


Trending Now

SARV Events & Celebrations Shines at "Edu-Bizz Leadership Summit & Awards 24July 18, 2024
UAE launches global initiative to build 10 hospitals to address critical healthcare gaps as part of Zayed Humanitarian Legacy InitiativeJuly 18, 2024
Geetanjali Homestate Expands Global Presence with the Launch of Geetanjali GlobalJuly 18, 2024
Changes projected in marine fish communities due to climate changeJuly 18, 2024
Understanding the Chandipura Virus Outbreak in Gujarat: A Critical OverviewJuly 18, 2024
Landmark Study Links Severe Endometriosis to Increased Risk of Ovarian CancerJuly 18, 2024
Equipping Healthcare Professionals for Global Opportunities: GIMS Partners with NSDCJuly 18, 2024
Hormone Modulating Therapy for Breast Cancer and Its Link to Lower Alzheimer’s RiskJuly 18, 2024
Multipl Secures $1.5 Million in Additional Funds, Led by Blume Ventures and MIXI Global Investments, JapanJuly 17, 2024
FedEx to empower youth with digital skilling programJuly 17, 2024
Putting people first means following Gandhi's TalismanJuly 17, 2024
American Oncology Institute (AOI) Launches #BreaktheHabit Campaign to Raise Awareness on Head & Neck cancerJuly 17, 2024
Chamraj Tea Estate Launches New Nilgiri Tea Blends: ‘Master Blend,’ ‘Master Blend Ginger Tea,’ and ‘Master Blend Lemon Tea’July 16, 2024
How a Fiber-Rich Diet and Gut Parasites Can Improve Your HealthJuly 16, 2024
LinkedIn: A Double-Edged Sword for Professional GrowthJuly 16, 2024
Food Safety and Drug Administration (FDA), Uttarakhand, National Association of Street Vendors of India (NASVI) and Nestlé India expand Project ‘Serve Safe Food’ in Uttarakhand July 16, 2024
IIT Kharagpur and University of Leeds Sign MoU for Joint Supervision of PhD ProgramsJuly 16, 2024
Puja Curtains go up with KHUTI PUJA at Hazra Park DurgotsabJuly 16, 2024
Algorand and SEWA Join Forces to Launch Digital Health Passport Initiative for Women's EmpowermentJuly 15, 2024
The Debate Over Menstrual Leave: Balancing Needs and Workplace EqualityJuly 15, 2024