Nasdaq GlobeNewswire

TESARO Receives Positive CHMP Opinion for ZEJULA®

Del

ZUG, Switzerland, Sept. 15, 2017 (GLOBE NEWSWIRE) -- TESARO, Inc. (NASDAQ:TSRO), an oncology-focused biopharmaceutical company, today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for the Company's marketing authorization application (MAA) for ZEJULA®(niraparib) as a monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete response (CR) or partial response (PR) to platinum-based chemotherapy. This opinion will now be referred to the European Commission (EC), which grants marketing authorization for medicines in the European Union. Pending the decision by the EC, ZEJULA would be the first oral, once-daily poly (ADP-ribose) polymerase (PARP) 1/2 inhibitor approved in Europe for use in patients regardless of BRCA mutation or biomarker status.

ZEJULA was approved by the Food and Drug Administration (FDA) on March 27, 2017 and is marketed by TESARO in the United States, where it is the most frequently prescribed PARP inhibitor.

"ZEJULA was studied with the highest level of clinical rigor, and the Phase 3 NOVA trial generated unsurpassed efficacy results in patients with recurrent ovarian cancer, including women without germline BRCA mutations who have the most challenging prognosis and few treatment options," said Mary Lynne Hedley, Ph.D., President and COO of TESARO. "Today's positive CHMP opinion brings us one step closer to providing this important new medicine to a broad population of patients with recurrent ovarian cancer in Europe." 

The ZEJULA marketing authorization application is supported by data from the ENGOT-OV16/NOVA trial, a double-blind, placebo-controlled, international Phase 3 study of ZEJULA that enrolled 553 patients with recurrent ovarian cancer who had achieved either a PR or CR to their most recent platinum-based chemotherapy. Approximately two-thirds of study participants did not have germline BRCA mutations. Progression in the NOVA study was determined by robust, unbiased, blinded central review to be the earlier of radiographic or clinical progression. ZEJULA significantly increased progression free survival (PFS) in patients with and without germline BRCA mutations as compared to the control arm. Treatment with ZEJULA reduced the risk of disease progression or death by 73% in patients with germline BRCA mutations (HR 0.27) and by 55% in patients without germline BRCA mutations (HR 0.45). The magnitude of benefit was similar for patients entering the trial with a PR or a CR.

The most common grade 3/4 adverse reactions to ZEJULA in the NOVA trial included thrombocytopenia (34%), anemia (25%), neutropenia (20%), and hypertension (9%). Following dose adjustment based on individual tolerability, the incidence of grade 3/4 thrombocytopenia was low; approximately 1% after month two. The majority of hematologic adverse events were successfully managed via dose modification, and discontinuation of therapy due to thrombocytopenia, neutropenia and anemia occurred in 3.3%, 1.9% and 1.4% of patients, respectively.

"This is an important milestone for TESARO, marking our second positive CHMP opinion for our portfolio in 2017. We are rapidly globalizing the Company's mission of providing transformative oncology therapies to those who need them most," said Orlando Oliveira, Senior Vice President and General Manager of TESARO International. "Upon final approval by the EC, we intend to launch ZEJULA across multiple countries in Europe where we already have an established, direct presence, beginning in the fourth quarter."

About Ovarian Cancer in Europe
Europe has one of the highest incidences of ovarian cancer in the world with approximately 45,000 women diagnosed there every year1 ,[2]. Ovarian cancer affects approximately 1.3 in 10,000 people in the European Union, where it is the sixth-most common cancer among women and the fifth-most frequent cause of cancer death among women3 ,[4]. Despite high initial response rates to platinum-based chemotherapy, approximately 85% of women with advanced ovarian cancer will experience a recurrence of the disease after first-line treatment. The efficacy of chemotherapy also diminishes over time.

About TESARO
TESARO is an oncology-focused biopharmaceutical company devoted to providing transformative therapies to people bravely facing cancer. For more information, visit www.tesarobio.com and follow us on Twitter and LinkedIn.

About ZEJULA (niraparib)
ZEJULA is an oral, once-daily poly (ADP-ribose) polymerase (PARP) 1/2 inhibitor that is indicated in the U.S. for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. The National Comprehensive Cancer Network (NCCN) added ZEJULA to the NCCN Clinical Practice Guidelines in Oncology Ovarian Cancer version 1.2017-April 12, 2017-as maintenance therapy for patients with platinum-sensitive disease who are in partial or complete response after completion of two or more lines of platinum-based chemotherapy. In preclinical studies, ZEJULA concentrates in the tumor relative to plasma, delivering greater than 90% durable inhibition of PARP 1/2 and a persistent antitumor effect.

Forward Looking Statements
To the extent that statements contained in this press release are not descriptions of historical facts regarding TESARO, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "anticipate," "estimate," "intend," and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements in this release involve substantial risks and uncertainties that could cause our clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, risks associated with competition in the PARP market, risks related to pricing and reimbursement, risks related to manufacturing and supply, risks related to intellectual property, and other risks and uncertainties that could affect the availability or commercial potential of ZEJULA. TESARO undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of the Company in general, see TESARO's Annual Report on Form 10-K for the year ended December 31, 2016 and Quarterly Report on Form 10-Q for the quarter ended June 30, 2017.

_________________________

1 World Cancer Research Fund International. http://www.wcrf.org (Last accessed 14 September 2017)

2 EUCAN (EU, EEA and Switzerland). http://eco.iarc.fr/eucan/CancerOne.aspx?Cancer=27&Gender=2 (Last accessed 14 September 2017)

3 EUCAN. http://eco.iarc.fr/eucan/CancerOne.aspx?Cancer=27&Gender=2  (Last accessed 14 September 2017)

4 CDC, https://www.cdc.gov/cancer/ovarian/statistics/index.htm (Last accessed 14 September 2017)

Global Media & Investor Contact: 
Jennifer Davis 
Vice President, Corporate Communications & Investor Relations 
+1.781.325.1116 or jdavis@tesarobio.com

Ex-U.S.  Media Contact: 
Shannon Altimari 
Head of Corporate Affairs, International 
+41 (0) 41 588 08 68 or saltimari@tesarobio.com 




This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: TESARO, Inc. via Globenewswire

Om Nasdaq GlobeNewswire

Nasdaq GlobeNewswire
Nasdaq GlobeNewswire
One Liberty Plaza - 165 Broadway
NY 10006 New York

+1 212 401 8700http://www.nasdaqomx.com

NASDAQ (NASDAQ: NDAQ) is a leading provider of trading, exchange technology, information and public company services across six continents.

Følg saker fra Nasdaq GlobeNewswire

Registrer deg med din epostadresse under for å få de nyeste sakene fra Nasdaq GlobeNewswire på epost fortløpende. Du kan melde deg av når som helst.

Siste saker fra Nasdaq GlobeNewswire

SEMAFO Mourns Passing of Board Chairman Jean Lamarre23.11.2017 22:01Pressemelding

MONTREAL, Nov. 23, 2017 (GLOBE NEWSWIRE) -- SEMAFO (TSX:SMF) (OMX:SMF) announces with sadness the passing of Mr. Jean Lamarre, Chairman of the Board of Directors of the Corporation, on November 22, 2017 following a short illness. Mr. Lamarre joined the Corporation's Board of Directors in 1997 and was appointed Chairman of the Board in 2000, a position he held until his demise. "Jean made an indelible mark on SEMAFO, both in terms of his corporate governance expertise and his 45 years of experience in Africa," said President and CEO Benoit Desormeaux. "Over his 20-year tenure with SEMAFO, he brought unique insight, business acumen and leadership to the Corporation as it transitioned from an exploration company to a junior gold producer. He did this, always without compromising his values: the integrity of the Corporation, his deep love for Africa and its people, and his priority to SEMAFO's long-term sustainability. On behalf of SEMAFO's Board of Directors, management and employe

Premier to join industry leaders at BDA London forum23.11.2017 21:39Pressemelding

HAMILTON, Bermuda, Nov. 23, 2017 (GLOBE NEWSWIRE) -- Premier David Burt will join more than two-dozen Bermuda executives in a multi-industry forum being held in London next week to showcase the breadth of expertise and advantages offered by the island's global business market. A photo accompanying this announcement is available at http://www.globenewswire.com/NewsRoom/AttachmentNg/78c5ac53-07f7-4dd8-83e0-753ea5b4c80b Organised by the Bermuda Business Development Agency (BDA), the one-day event Tuesday, November 28 at ME London has attracted over 200 registrants. It will feature top regulatory and industry leaders in moderated discussion panels covering re/insurance, captive insurance, insurance-linked securities, asset management, family offices, and trust and private-client business. A networking reception will wrap the event in the evening. "The government supports the Bermuda Business Development Agency in this awareness-raising event that offers such gre

Crown Bioscience and Data Sciences International (DSI) Partner to Advance Metabolic Disease Research Using an Implanted Telemetry Device for Long-Term Blood Glucose Monitoring23.11.2017 14:00Pressemelding

SANTA CLARA, Calif., Nov. 23, 2017 (GLOBE NEWSWIRE) -- Crown Bioscience, a wholly-owned subsidiary of Crown Bioscience International (TWSE: ticker 6554) and a global drug discovery and development services company providing translational platforms to advance oncology, inflammation cardiovascular and metabolic disease research, announces the successful development of an enhanced method for preclinical obesity and type 2 diabetes studies in partnership with Data Sciences International (DSI). Crown Bioscience's clinically relevant models and DSI's HD-XG implantable glucose device combine to create a superior approach to preclinical metabolic disease research. Recently published work in the Journal of Endocrinological Investigation and Nature's Scientific Reports demonstrates the advantages of a new method using DSI's HD-XG implantable glucose device and Crown Bioscience's models of spontaneous and diet-induced diabetes. The HD-XG device allows for continuous, long-term measurement

Euroloan Opens New Market in Spain23.11.2017 11:10Pressemelding

Helsinki, Finland, 2017-11-23 11:10 CET (GLOBE NEWSWIRE) -- According to James Hickson, CEO of Euroloan Group, initiating services in the Spanish market is a key step in the expansion strategy of the Fintech group. “We have seen a growing demand for easy payment solutions in several markets, and the Spanish market in particular offers a massive opportunity for growth with Euroloan’s advanced payment and credit solutions. Merchants and Consumers appreciate our simple, fast and efficient services. It’s all about making their life easier. Consistent with our strategy, we have identified a number of partners to accelerate our market entry approach and expect to be providing our lending and merchant solutions by the end of the 1Q 2018” The Group is now present in five countries in Europe, including Finland, Sweden, Poland, Luxembourg and Spain. “Euroloan aims to open up several additional new markets”, says Tommi Lindfors, Chairman of the Board of Euroloan Group. “Spain is an importan

BDA partners with government to attract cryptocurrency23.11.2017 06:25Pressemelding

HAMILTON, Bermuda, Nov. 23, 2017 (GLOBE NEWSWIRE) -- The Bermuda Business Development Agency (BDA) will take a lead role in an initiative launched by the Bermuda government today to accelerate the establishment and growth of digital currency business on the island. A photo accompanying this announcement is available at http://www.globenewswire.com/NewsRoom/AttachmentNg/457f43b9-d7bb-48f1-83e2-b856b33ebacc At a press conference held by Premier the Hon David Burt and National Security Minister the Hon Wayne Caines, the government announced the formation of a task force comprising two teams to advance Bermuda's regulatory environment as a destination for utility tokens, tokenised securities, cryptocurrencies, and coin offerings. BDA Consultant for Emerging Technologies John Narraway was named as chair of the Blockchain Business Development Working Group, while BDA Board member Lydia Dickens will chair the Blockchain Legal and Regulatory Working Group, of which

VistaJet Partners With Christie's for the Global Tour of The Collection of Peggy and David Rockefeller22.11.2017 11:39Pressemelding

The sale will be the most significant philanthropic auction ever presented LONDON, Nov. 22, 2017 (GLOBE NEWSWIRE) -- VistaJet, the first and only global private aviation company, announces today its worldwide sponsorship of the exhibition and tour of The Collection of Peggy and David Rockefeller, the most significant auction entirely dedicated to raising funds for philanthropic causes.  The sale, consisting of numerous categories, will be conducted by Christie's, the world's leading art business, and will include a highlights exhibition tour in Hong Kong, London, Los Angeles and New York. Photos accompanying this announcement are available at http://www.globenewswire.com/NewsRoom/AttachmentNg/c78fdce7-7651-42a8-a621-14088da2cc86 http://www.globenewswire.com/NewsRoom/AttachmentNg/33af2489-a9a8-4bbe-b5f7-78e4c1f29ca2 http://www.globenewswire.com/NewsRoom/AttachmentNg/a16c2

I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.

Besøk vårt presserom