Stefan Bernstein explains how the EU/Greenland critical raw materials partnership benefits GreenRoc. Watch the full video here.

Less Ads, More Data, More Tools Register for FREE

Pin to quick picksAstrazeneca Regulatory News (AZN)

Share Price Information for Astrazeneca (AZN)

London Stock Exchange
Share Price is delayed by 15 minutes
Get Live Data
Share Price: 10,678.00
Bid: 10,688.00
Ask: 10,690.00
Change: -64.00 (-0.60%)
Spread: 2.00 (0.019%)
Open: 10,756.00
High: 10,780.00
Low: 10,674.00
Prev. Close: 10,742.00
AZN Live PriceLast checked at -

Watchlists are a member only feature

Login to your account

Alerts are a premium feature

Login to your account

Lynparza Granted BTD in US for Prostate Cancer

28 Jan 2016 07:00

RNS Number : 2605N
AstraZeneca PLC
28 January 2016
 

 

LYNPARZA™ (Olaparib) granted Breakthrough Therapy Designation by US FDA for treatment of BRCA1/2 or ATM gene mutated metastatic Castration Resistant Prostate Cancer

AstraZeneca today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation (BTD) for the oral poly ADP-ribose polymerase (PARP) inhibitor Lynparza™ (olaparib), for the monotherapy treatment of BRCA1/2 or ATM gene mutated metastatic Castration Resistant Prostate Cancer (mCRPC) in patients who have received a prior taxane-based chemotherapy and at least one newer hormonal agent (abiraterone or enzalutamide). 

The FDA criteria for BTD require preliminary clinical evidence that demonstrates a drug may have substantial improvement on at least one clinically significant endpoint over available therapy. The decision to assign a BTD for Lynparza is based on the results of the TOPARP-A Phase II trial, which found that Lynparza (olaparib) monotherapy in mCPRPC may offer substantial improvement over available therapies for the treatment of the biomarker-selected population with this serious and life-threatening condition. The TOPARP-A Phase II trial was presented at AACR 2015 and published in the New England Journal of Medicine in October 2015[i]. It showed that men with prostate cancer with defective DNA damage repair mechanisms responded to Lynparza (olaparib).

 

The Breakthrough Therapy designation for Lynparza in this patient population means the FDA will expedite review of submission data within 60 days of receipt.

Antoine Yver, Head of Oncology, Global Medicines Development at AstraZeneca, said: "More than 27,000 men died of prostate cancer last year in the US alone. The Breakthrough Therapy designation for Lynparza is encouraging news for patients, and their families, as there are currently very limited treatment options for metastatic Castration Resistant Prostate Cancer. We will work closely with the FDA to introduce Lynparza as a new treatment option as soon as possible."

 

Once prostate cancer has progressed to mCPRPC, treatment focuses on extending life, delaying disease progression, and improving symptoms and quality of life. Overall survival time for patients treated with chemotherapy and newer hormonal agents is 10 months[ii]. There are also no approved therapies for third line and above (3L+) mCRPC patients, and no targeted therapies are available for mCRPC patients with somatic or germline mutations in BRCA1, BRCA2 or ATM.

 

Lynparza (olaparib) is an innovative, first-in-class oral poly ADP-ribose polymerase (PARP) inhibitor that exploits tumour DNA repair pathway deficiencies to preferentially kill cancer cells. This mode of action gives olaparib the potential for activity in a range of tumour types with DNA repair deficiencies.

 

Lynparza has been approved by regulatory authorities in 40 countries for the maintenance treatment of women with BRCA-mutated ovarian cancer. AstraZeneca is investigating the potential of olaparib in other PARP dependent tumours. Phase III studies in gastric cancer, pancreatic cancer and adjuvant and metastatic BRCAm breast cancers are underway, with further studies planned.

 

NOTES TO EDITORS

 

About prostate cancer

 

In 2015, 27,540 US men died of prostate cancer[iii]. Based on the Global Burden of Disease Cancer Collaboration, there were 1.4 million incidents of prostate cancer and 293,000 deaths worldwide for the year 2013. Prostate cancer caused 4.8 million disability-adjusted life-years globally in 2013, with 57% occurring in developed countries and 43% occurring in developing countries[iv].

About AstraZeneca in Oncology

Oncology is a therapy area in which AstraZeneca has deep-rooted heritage. It will be potentially transformational for the company's future, becoming the sixth growth platform. Our vision is to help patients by redefining the cancer treatment paradigm and one day eliminate cancer as a cause of death. By 2020, we are aiming to bring at least six new cancer medicines to patients.

Our broad pipeline of next-generation medicines is focused on four main disease areas - lung, ovarian, breast and haematological cancers. These are being targeted through four key platforms - immuno-oncology, the genetic drivers of cancer and resistance, DNA damage repair and antibody drug conjugates - with a strong focus on combinations. Our recently announced investment in Acerta Pharma also adds the potentially transformational BTK inhibitor class of treatments to our portfolio, subject to closure in the first quarter of 2016, strengthening further our focus on targeted therapies.

About AstraZeneca

AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three main therapy areas - respiratory, inflammation, autoimmune disease (RIA), cardiovascular and metabolic disease (CVMD) and oncology - as well as in infection and neuroscience. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information please visit: www.astrazeneca.com

 

CONTACTS

 

Media Enquiries

 

 

 

Esra Erkal-Paler

 

UK/Global

+44 20 7604 8030

Neil Burrows

UK/Global

+44 20 7604 8032

Vanessa Rhodes

 

UK/Global

+44 20 7604 8037

Karen Birmingham

UK/Global

+44 20 7604 8120

Jacob Lund

 

Sweden

+46 8 553 260 20

Michele Meixell

US

+1 302 885 2677

Investor Enquiries

UK

Thomas Kudsk Larsen

 

Oncology

+44 7818 524185

Eugenia Litz

RIA

 

+44 7884 735627

Nick Stone

CVMD

 

+44 7717 618834

Craig Marks

Finance

+44 7881 615764

Christer Gruvris

 

Consensus Forecasts

+44 7827 836825

US

Lindsey Trickett

Oncology, ING

+1 240 543 7970

Mitch Chan

Oncology

+1 240 477 3771

Dial / Toll-Free

 +1 866 381 7277

 

Key: RIA - Respiratory, Inflammation and Autoimmunity, CVMD - Cardiovascular and Metabolic Disease,

ING - Infection, Neuroscience and Gastrointestinal

28 January 2016

 

-ENDS-


[i]Mateo J, et al. DNA-Repair Defects and Olaparib in Metastatic Prostate Cancerhttp://www.nejm.org/doi/full/10.1056/NEJMoa1506859?af=R&rss=currentIssue&

[ii] Smith MR, DeBono JS, Sternberg CN, Le Moulec S, Oudard S, De Giorgi U et al. Final analysis of COMET-1: Cabozantinib (Cabo) versus prednisone (Pred) in metastatic castration-resistant prostate cancer (mCRPC) patients (pts) previously treated with docetaxel (D) and abiraterone (A) and/or enzalutamide (E).ASCO GU 2015. J Clin Oncol 2015;33(7):abstr 139.[iii] National Cancer Institute 2015. http://www.cancer.gov/types/common-cancers accessed September 2015

[iv]Global Burden of Cancer Coalition. The Global Burden of Cancer 2013. JAMA Oncol. 2015;1(4):505-527. doi:10.1001/jamaoncol.2015.0735. http://oncology.jamanetwork.com/article.aspx?articleid=2294966#ArticleInformation

This information is provided by RNS
The company news service from the London Stock Exchange
 
END
 
 
MSCUWUNRNUAAURR
Date   Source Headline
25th Mar 20247:00 amRNSUltomiris approved in the US for NMOSD
19th Mar 20247:00 amRNSAstraZeneca to acquire Fusion
14th Mar 20247:00 amRNSAstraZeneca to acquire Amolyt
12th Mar 202411:00 amRNSDirector/PDMR Shareholding
7th Mar 202411:00 amRNSNotice of AGM
6th Mar 20243:05 pmRNSDirector/PDMR Shareholding
6th Mar 20243:00 pmRNSDirector/PDMR Shareholding
4th Mar 20247:00 amRNSEMA validates Dato-DXd MAAs for NSQ NSCLC and BC
1st Mar 20243:00 pmRNSTotal Voting Rights
26th Feb 20247:00 amRNSVoydeya recommended for EU approval
22nd Feb 20241:15 pmRNSAcquisition of Gracell completed
22nd Feb 202411:00 amRNSDirector/PDMR Shareholding
22nd Feb 20247:00 amRNSAstraZeneca prices a $5bn bond offering
21st Feb 20247:00 amRNSFiling of Form 20-F with SEC
20th Feb 202411:00 amRNSAnnual Financial Report
19th Feb 20243:00 pmRNSAstraZeneca completes acquisition of Icosavax
19th Feb 20247:10 amRNSTagrisso plus chemo approved in US for lung cancer
19th Feb 20247:05 amRNSFDA accepts Dato-DXd BLA for nonsquamous NSCLC
19th Feb 20247:00 amRNSTagrisso improved PFS in Stage III lung cancer
8th Feb 20247:00 amRNSFinal Results
1st Feb 20243:00 pmRNSTotal Voting Rights
2nd Jan 20243:00 pmRNSTotal Voting Rights
27th Dec 20237:00 amRNSAstraZeneca acquires Gracell
22nd Dec 20237:00 amRNSWainua (eplontersen) granted first US FDA approval
14th Dec 20233:00 pmRNSDirector/PDMR Shareholding
12th Dec 20237:05 amRNSAstraZeneca to acquire Icosavax
1st Dec 20233:05 pmRNSBlock listing Interim Review
1st Dec 20233:00 pmRNSTotal Voting Rights
1st Dec 20237:00 amRNSDiscontinuation of two CRYSTALIZE evidence trials
23rd Nov 20233:00 pmRNSDirector/PDMR Shareholding
17th Nov 20237:00 amRNSTruqap approved in US for HR+ breast cancer
14th Nov 20237:05 amRNSUpdate on PACIFIC-2 Phase III trial for Imfinzi
9th Nov 20233:00 pmRNSDirector Declaration
9th Nov 20237:10 amRNSImfinzi combination improves PFS in liver cancer
9th Nov 20237:05 amRNSAgreement with Eccogene for clinical stage GLP-1RA
9th Nov 20237:00 amRNS9M and Q3 2023 results
1st Nov 20233:00 pmRNSTotal Voting Rights
1st Nov 20237:00 amRNSAstraZeneca cell & gene therapy deal w/ Cellectis
3rd Oct 20237:00 amRNSAstraZeneca settles Nexium liability litigations
2nd Oct 20233:00 pmRNSTotal Voting Rights
22nd Sep 20237:00 amRNSDato-DXd improved PFS in breast cancer
20th Sep 20237:00 amRNSAlexion completes Pfizer gene therapy agreement
15th Sep 20233:00 pmRNSEnhertu recommended in EU for HER2-mutant NSCLC
11th Sep 20234:00 pmRNSFasenra Phase III EGPA trial met primary endpoint
6th Sep 20237:00 amRNSUpdate on US review of Ultomiris for NMOSD
1st Sep 20233:00 pmRNSTotal Voting Rights
1st Aug 20233:00 pmRNSTotal Voting Rights
28th Jul 20237:05 amRNSAlexion enters gene therapy agreement with Pfizer
28th Jul 20237:00 amRNSHalf-year Report
17th Jul 20236:10 pmRNSBeyfortus approved in US for infant RSV prevention

Due to London Stock Exchange licensing terms, we stipulate that you must be a private investor. We apologise for the inconvenience.

To access our Live RNS you must confirm you are a private investor by using the button below.

Login to your account

Don't have an account? Click here to register.

Quickpicks are a member only feature

Login to your account

Don't have an account? Click here to register.