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

Nitinat Appoints John A. Gould as its Qualified Person for its Carscallen Gold Property19.2.2018 22:30Pressemelding

TORONTO, Feb. 19, 2018 (GLOBE NEWSWIRE) -- Nitinat Minerals Corporation (TSX VENTURE:NZZ) (FRANKFURT:04U1) (the "Corporation") is pleased to announce that Mr. John Alan Gould has been appointed the Qualified Person in respect of the Corporation's Carscallen Gold Property (the "Property"). Mr. Gould, who has extensive experience with geological formations similar to those found on the Property, has completed a review of the Property and has developed an initial work program. Mr. Gould, who is 60 years old and a citizen of South Africa, holds a B.Sc. degree (Geology, Physics and Chemistry) from the University of Witwatersrand. At the start of Mr. Gould's career, he was initially involved in Witwatersrand and Bushveld-type mining operations in South Africa. His experience includes all aspects of mining and geological aspects that extended over deep and shallow level gold mining operations (Venterspost, East Driefontein, Randfontein Estates, Joel Gold Mine, ERPM, Grootvlei Gold Mine, Harmo

Standard Lithium Announces Closing of $21.6 million Bought Deal Private Placement of Units16.2.2018 19:25Pressemelding

THIS NEWS RELEASE IS INTENDED FOR DISTRIBUTION IN CANADA ONLY AND IS NOT INTENDED FOR DISTRIBUTION TO UNITED STATES NEWSWIRE SERVICES OR DISSEMINATION IN THE UNITED STATES. VANCOUVER, British Columbia, Feb. 16, 2018 (GLOBE NEWSWIRE) -- Standard Lithium Ltd. ("Standard Lithium" or the "Company") (TSX-V:SLL) (OTCQX:STLHF) (FRA:S5L) announced today that it has closed its previously announced bought deal private placement of 10,312,821 units of the Company (the "Units"), at a price of $2.10 per Unit, for aggregate gross proceeds to the Company of $21,656,924, including the issuance and sale of the Underwriters' (as defined below) option (the "Offering"). Each Unit consists of one common share of the Company and one-half of one common share purchase warrant (each whole common share purchase warrant, a "Warrant"). Each Warrant is exercisable to acquire one common share of the Company (a "Warrant Share") until February 16, 2020 at an exercise price of $2.60 per Warrant Share, subject to adjus

Cisco Offers Cloud-Based Endpoint Security Solutions for Managed Security Service Providers16.2.2018 14:00Pressemelding

Cisco's comprehensive cloud-based security endpoint portfolio provides advanced malware protection, internet security, and enterprise mobility management SAN JOSE, Calif., Feb. 16, 2018 (GLOBE NEWSWIRE) -- Cisco today is helping address the challenges of Managed Security Service Providers (MSSP) and their customers by offering MSSPs comprehensive security, visibility, and control of customer endpoints without added hardware or complexity. The Cisco endpoint security portfolio includes three industry-leading solutions-Cisco AMP for Endpoints, Cisco Umbrella, and Meraki Systems Manager to offer protection against advanced malware and threats. Security teams know the endpoints in their environments are being targeted by advanced threats, but often lack the security talent, tools, and budget to address those challenges. As a result, organizations of all sizes are choosing to augment their in-house IT security with managed security services. Nearly half of SMBs and enterprises in the US1 ar

Aurora Solar Adds Heterojunction Cell Characterization to Decima Gemini Family16.2.2018 14:00Pressemelding

Aurora Solar Technologies Inc. / Aurora Solar Adds Heterojunction Cell Characterization to Decima Gemini Family . Processed and transmitted by Nasdaq Corporate Solutions. The issuer is solely responsible for the content of this announcement. NORTH VANCOUVER, British Columbia, Feb. 16, 2018 (GLOBE NEWSWIRE) -- Aurora Solar Technologies Inc. ("Aurora") ("Company") (TSX.V:ACU) (OTCBB:AACTF) (FSE:A82) is pleased to provide an update on the further development of its Decima Gemini(TM) infrared measurement technology for applications in the rapidly developing heterojunction (HJT) cell manufacturing market. HJT is an ultra high-efficiency solar cell design pioneered by Japan's Panasonic Corp., who is now also partnered with Tesla Inc. for solar products. According to Solar Media Ltd., HJT production capacity is expected to increase by 20 percent this year. To produce the electrical structure of a HJT cell, it is necessary to apply thin layers of amorphous silicon on both sides of a crystallin

Nasdaq Cited as a Leader in Governance, Risk, and Compliance Platforms by Independent Research Firm16.2.2018 13:35Pressemelding

NEW YORK, Feb. 16, 2018 (GLOBE NEWSWIRE) -- Nasdaq (Nasdaq:NDAQ) was among the select companies that Forrester invited to participate in its 2018 Forrester Wave(TM) evaluation, Governance, Risk, And Compliance (GRC) Platforms, Q1 2018. In this evaluation, Nasdaq was cited as a Leader in Governance, Risk, and Compliance Platforms and received the maximum score of 5 for the evaluation criteria "Risk & Control Management", "Audit Management", "Dashboard and Reporting" and "Integration capabilities" for its BWise solutions. "We feel the strong scores we obtained in important functional areas provide assurance to our clients that they have selected a robust and future-proof software platform," said Tom Passon, Head of Product Innovation & Global Standards, Nasdaq BWise. "We are proud of this recognition that encourages us to further execute on our strategy to provide user-friendly, pre-configured best practice solutions that combine our innovative GRC software platform with leading expertis

Apricus Biosciences Receives Complete Response Letter from FDA for Vitaros(TM)16.2.2018 13:00Pressemelding

Company Evaluating Deficiencies and Potential Path Forward SAN DIEGO, Feb. 16, 2018 (GLOBE NEWSWIRE) -- Apricus Biosciences, Inc. (Nasdaq:APRI), a biopharmaceutical company advancing innovative medicines in urology and rheumatology, today announced that the U.S. Food and Drug Administration ("FDA") has issued a complete response letter ("CRL") for the New Drug Application ("NDA") of Vitaros(TM) (alprostadil, DDAIP.HCl), a topical cream for the treatment of erectile dysfunction. The CRL indicates that the FDA cannot approve the NDA for Vitaros in its present form, identifying deficiencies related to Chemistry, Manufacturing and Control ("CMC") and certain safety concerns specific to the 2.5% concentration of DDAIP.HCl contained in the current formulation. "We are disappointed with the outcome of the review given the substantial amount of CMC, clinical and non-clinical data and analysis provided to the FDA in the Vitaros resubmission. We are assessing the content of the complete response

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

Besøk vårt presserom