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    AZN   GB0009895292

ASTRAZENECA PLC

(AZN)
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Delayed London Stock Exchange  -  11:35 2022-09-28 am EDT
10076.00 GBX   +1.54%
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Lynparza in combination with abiraterone granted Priority Review in the US for patients with metastatic castration-resistant prostate cancer

08/16/2022 | 11:50am EDT

* First PARP inhibitor to demonstrate clinical benefit in combination with a new hormonal agent irrespective of homologous recombination repair (HRR) gene mutations

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).

Lynparza is being jointly developed and commercialised by AstraZeneca and MSD.

The Food and Drug Administration (FDA) grants Priority Review to applications for medicines that offer significant advantages over available options by demonstrating safety or efficacy improvements, preventing serious conditions, or enhancing patient compliance.1 The Prescription Drug User Fee Act date, the FDA action date for their regulatory decision, is anticipated during the fourth quarter of 2022.

In the US, prostate cancer is the second most common cancer in male patients and is projected to cause approximately 35,000 deaths in 2022.2 Overall survival for patients with mCRPC is approximately three years in clinical trial settings, and even shorter in the real world.3-6 Approximately half of patients with mCRPC may receive only one line of active treatment, with diminishing benefit of subsequent therapies.6-11

Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: "There remains a critical unmet need among patients diagnosed with metastatic castration-resistant prostate cancer, where the prognosis remains poor and treatment options are limited. Today's news is another step towards bringing forward a new, much-needed treatment option in this setting. If approved, Lynparza with abiraterone will become the first combination of a PARP inhibitor and a new hormonal agent for patients with this disease."

Dr. Eliav Barr, Senior Vice President, Head of Global Clinical Development and Chief Medical Officer, MSD Research Laboratories, said: "MSD is committed to developing new treatment options for patients with metastatic castration-resistant prostate cancer, a complex disease that urgently needs more therapies. We look forward to working with the FDA towards the goal of bringing a new option to patients with mCRPC with or without HRR gene mutations."

The sNDA was based on results from the PROpel Phase III trial presented at the 2022 American Society of Clinical Oncology (ASCO) Genitourinary Cancers Symposium and later published in NEJM Evidence.

These results showed Lynparza in combination with abiraterone reduced the risk of disease progression or death by 34% versus abiraterone alone (based on a hazard ratio [HR] of 0.66; 95% confidence interval [CI] 0.54-0.81; p

.

(C) 2022 M2 COMMUNICATIONS, source M2 PressWIRE

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Financials (USD)
Sales 2022 44 322 M - -
Net income 2022 4 574 M - -
Net Debt 2022 24 523 M - -
P/E ratio 2022 38,4x
Yield 2022 2,73%
Capitalization 168 B 168 B -
EV / Sales 2022 4,34x
EV / Sales 2023 4,02x
Nbr of Employees 83 100
Free-Float 96,5%
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Number of Analysts 27
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Pascal Soriot Chief Executive Officer & Executive Director
Aradhana Sarin Chief Financial Officer & Executive Director
Leif Valdemar Johansson Non-Executive Chairman
Menelas NICOLAS Pangalos EVP-Biopharmaceuticals Research & Development
Pam P. Cheng Executive VP-Operations & Information Technology
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