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...

-Advertisements-




Trending Now

The Neurological Toll of Common Household Chemicals: Insights from Recent ResearchMarch 28, 2024
The Aging Puzzle: Decoding the Mechanisms of AgingMarch 28, 2024
The Double-Edged Sword of Kala-azar Treatment: Shedding Light on Eye ComplicationsMarch 28, 2024
FTCCI Launches Industry-Academia Connect to improve the employability of Engineering Graduates and address the growing demand for Talent in Emerging TechMarch 27, 2024
NTT and Olympus Begin World's First Joint Demonstration Experiment of Cloud Endoscopy SystemMarch 27, 2024
NTT and Olympus Begin World's First Joint Demonstration Experiment of Cloud Endoscopy SystemMarch 27, 2024
2nd Edition of IIFL JITO Ahimsa Run for peace & for non-violence to be held on 31st MarchMarch 27, 2024
Brij Hotels Announced 4 Million in Series A Funding March 27, 2024
Combatting Childhood Sedentariness: The Key to Preventing Premature Vascular DamageMarch 27, 2024
Crucial Findings: Unlocking Paths to Combat Ebola's DevastationMarch 27, 2024
Guarding Against Disease: The Crucial Role of Oral Hygiene in Preventive HealthcareMarch 27, 2024
Sanofi & Cipla announce exclusive distribution partnership to expand reach of CNS portfolio in IndiaMarch 26, 2024
Surmandal's Tribute to the Legends of Hindustani Classical MusicMarch 26, 2024
In Moscow, over 350,000 mammograms have been analyzed using artificial intelligence as part of the compulsory health insurance programMarch 26, 2024
Embark on a Creative Journey: "Kala For A Cause" Unveils Pottery Workshop Series March 26, 2024
Healthtech pioneer Aurora Innovation appoints new CEO – expands in Europe with service that streamlines patient-healthcare interactionMarch 26, 2024
In A Rare Feat, 45 YO Woman Walks Within 6 Hrs. Of Dual Robotic Surgery In A Single Operation At HCGMCCMarch 26, 2024
Improve Cancer Care through Automated CT Analysis: Oncoshield – CTMarch 26, 2024
Empowering Patients: The Role of Advocacy in Indian HealthcareMarch 26, 2024
A New Dawn in Heart Surgery: Mitral Valve Repair for 15-Year-Old PatientMarch 26, 2024