CHMP Grants Positive Opinion for Clovis Oncology’s Rubraca® (rucaparib) Tablets
Clovis Oncology, Inc. (NASDAQ: CLVS) today announced that the European Union’s (EU) European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the granting of a conditional marketing authorization for Rubraca as monotherapy treatment of adult patients with platinum sensitive, relapsed or progressive, BRCA mutated (germline and/or somatic), high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have been treated with two or more prior lines of platinum based chemotherapy, and who are unable to tolerate further platinum based chemotherapy.
The European Marketing Authorization application for the treatment indication was based on objective response rate and duration of response results from two multicenter, single-arm, open-label clinical trials, Study 10 and ARIEL2, in women with advanced BRCA mutant ovarian cancer who had progressed after two or more prior chemotherapies.
“The recommendation to approve Rubraca as monotherapy is welcome news, as once approved it will offer a new treatment option for women with advanced, recurrent ovarian cancer who have BRCA mutant platinum sensitive disease and are unsuitable for platinum based chemotherapy. In this analysis, we observed many women benefiting from extended progression-free survival with acceptable tolerability,” said Dr. Rebecca Kristeleit, Clinical Senior Lecturer and Consultant Medical Oncologist, University College London/University College London Hospitals UK. “These are really important data demonstrating meaningful efficacy and a new non-chemotherapy treatment option for this group of patients who have already been exposed to a number of chemotherapy regimens.”
Ovarian cancer is the sixth deadliest cancer amongst women in Europe, where more than 65,000 women are diagnosed annually.i Ovarian cancer is challenging to treat, and most women will relapse after surgery and chemotherapy. The 80 to 85 percent of women diagnosed in the later stages of the disease (III and IV) have particularly poor outcomes.ii Approximately one in four women with ovarian cancer have a germline or somatic BRCA mutation,iii and new treatment options are needed to treat unique patient populations.
“We are extremely pleased to have received a positive recommendation for approval for Rubraca in an ovarian cancer treatment indication, and we look forward to receiving the formal approval from the European Commission in second quarter 2018,” said Patrick J. Mahaffy, President and CEO of Clovis Oncology. “This is great news for women living with this difficult disease who often have limited options available. In addition, this opinion from CHMP paves the way for the review of Rubraca in the ovarian cancer maintenance indication, based on the ARIEL3 data. We intend to file a variation to the Marketing Authorization (MA) in June, with a potential recommendation for approval in the broader maintenance indication by the end of 2018.”
Pending approval for the treatment indication, Clovis plans to submit the variation to the MA based on data from the phase 3 ARIEL3 clinical trial, which found that rucaparib significantly improved progression-free survival in all ovarian cancer patient populations studied. ARIEL3 is a double-blind, placebo-controlled trial of rucaparib that enrolled 564 women with platinum-sensitive, high-grade ovarian, fallopian tube, or primary peritoneal cancer. The primary efficacy analysis evaluated three prospectively defined molecular sub-groups in a step-down manner: 1) BRCA mutant (BRCAmut+); 2) HRD positive (HRD+) inclusive of BRCA mutant; and finally, 3) the intent-to-treat population, or all patients treated in ARIEL3. The study achieved its primary endpoint of improved PFS by investigator review in each of three populations. The variation to the MA will be directed at the broader intent-to-treat or “all comers” population.
About Rubraca ® (rucaparib)
Rubraca is an oral, small molecule inhibitor of PARP1, PARP2 and PARP3 being developed in ovarian cancer as well as several additional solid tumor indications. Studies open for enrollment or under consideration include ovarian, prostate, breast, gastroesophageal, pancreatic, lung and bladder cancers. Clovis holds worldwide rights for Rubraca.
In the United States, Rubraca is approved on an accelerated basis as monotherapy for the treatment of patients with deleterious BRCA mutation (germline and/or somatic) associated advanced ovarian cancer, who have been treated with two or more chemotherapies, and selected for therapy based on an FDA-approved companion diagnostic for Rubraca. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. In December 2017, the U.S. Food and Drug Administration (FDA) accepted the Company’s supplemental New Drug Application (sNDA) for Rubraca for a second-line or later maintenance treatment indication in ovarian cancer based on the ARIEL3 data. The FDA granted Priority Review status to the application with a Prescription Drug User Fee Act (PDUFA) date of April 6, 2018.
Rubraca is an unlicensed medical product outside of the U.S.
About Clovis Oncology
Clovis Oncology, Inc. is a biopharmaceutical company focused on acquiring, developing and commercializing innovative anti-cancer agents in the U.S., Europe and additional international markets. Clovis Oncology targets development programs at specific subsets of cancer populations, and simultaneously develops, with partners, diagnostic tools intended to direct a compound in development to the population that is most likely to benefit from its use. Clovis Oncology is headquartered in Boulder, Colorado, and has additional offices in San Francisco, California and Cambridge, UK. Please visit clovisoncology.com for more information.
To the extent that statements contained in this press release are not descriptions of historical facts regarding Clovis Oncology, 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. Examples of forward-looking statements contained in this press release include, among others, statements regarding our expectation of timing for European Commission approval of rucaparib for the treatment indication and the filing of a variation to the MA for a maintenance indication for rucaparib. Such forward-looking statements involve substantial risks and uncertainties that could cause our future results, performance or achievements to differ significantly from that expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in actions by the FDA, the EMA or other regulatory authorities regarding whether to approve drug applications that may be filed, as well as their decisions that may affect drug labeling, pricing and reimbursement, and other matters that could affect the availability or commercial potential of our drug candidates or companion diagnostics. Clovis Oncology does not undertake to update or revise any forward-looking statements. A further description of risks and uncertainties can be found in Clovis Oncology’s filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K and its reports on Form 10-Q and Form 8-K.
i World Health Organization. Globocan 2012: estimated cancer
incidence, mortality and prevalence worldwide in 2012. Accessed 23
ii American Cancer Society. Survival rates for ovarian cancer, by stage. https://www.cancer.org/cancer/ovarian-cancer/detection-diagnosis-staging/survival-rates.html
iii Pennington KP, Walsh T, Harrell MI, et al. Germline and somatic mutations in homologous recombination genes predict platinum response and survival in ovarian, fallopian tube, and peritoneal carcinomas. Clin Cancer Res. 2014;20(3):764–775.
Clovis Investor Contacts:
Anna Sussman, 303.625.5022
Breanna Burkart, 303.625.5023
Clovis Media Contacts:
Lisa Guiterman, 301.217.9353
Christy Curran, 615.414.8668
Ann Hughes, +44 (0) 7956 700 790
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Tilaa tiedotteet sähköpostiisi
Haluatko tietää asioista ensimmäisten joukossa? Kun tilaat mediatiedotteemme, saat ne sähköpostiisi välittömästi julkaisuhetkellä. Tilauksen voit halutessasi perua milloin tahansa.
Lue lisää julkaisijalta Business Wire
CORRECTING AND REPLACING Teleperformance Groups ‘Praxidia Knowledge Services’ partners with CallMiner to launch TP Interact – a Comprehensive Interaction Analytics Solution22.5.2019 21:08:00 EEST | Tiedote
Please replace the release sent on May 21 2019 03:00 AM ET with the following corrected version due to multiple revisions. The corrected release reads: TELEPERFORMANCE GROUPS ‘PRAXIDIA KNOWLEDGE SERVICES’ PARTNERS WITH CALLMINER TO LAUNCH TP INTERACT – A COMPREHENSIVE INTERACTION ANALYTICS SOLUTION Praxidia Knowledge Services, a specialised subsidiary of the Teleperformance Group, today announced its strategic partnership with CallMiner to launch a customer solution called TP Interact. This speech and customer engagement analytics solution will optimise agent quality and customer satisfaction within contact centres across the globe. TP Interact’s managed analytics and consulting services, powered by the CallMiner Eureka speech analytics platform, is scalable in terms of both capacity and geography. This allows organisations across industry verticals to benefit from the invaluable insights driven by its customer interactions, regardless of call volume or channel. Through this partnershi
Mary Kay Inc.’s David Holl Named Among Top Ten Most Reputable CEOs in the World, According to Reputation Institute22.5.2019 20:00:00 EEST | Tiedote
Mary Kay Inc., a global beauty brand, today announced that Chairman and CEO David Holl is among the top ten most reputable chief executives in the world according to the Reputation Institute’s CEO RepTrak 2019. The Reputation Institute, the world’s leading provider of reputation measurement, measured the reputation of more than 140 global CEOs and canvassed more than 230,000 individual ratings among the informed public. The study was conducted in January and February of this year. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190522005604/en/ David Holl, CEO Mary Kay Inc. (Photo: Mary Kay Inc.) “David’s leadership and operational expertise since being named CEO in 2006 has contributed significantly to Mary Kay’s success,” said Richard R. Rogers, son of Mary Kay Ash, co-founder and Executive Chairman of the Board. “Mary Kay is a brand born of purpose, and David’s steadfast commitment to our founding values has made him a tru
Secure-D Exposes Suspicious Android App with 500 Million Downloads22.5.2019 16:49:00 EEST | Tiedote
Upstream, a leading mobile technology company, has unveiled that the popular Android application VidMate triggers suspicious background activity. Hidden software within the app delivers invisible ads, generates fake clicks and purchases, installs other suspicious apps without consent and collects personal users’ information. Consequently, it depletes users’ data allowance and brings unwanted charges. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190522005501/en/ With over 500 million downloads reported, VidMate is a popular Android application for streaming and downloading videos and songs from services such as Dailymotion, Vimeo, and YouTube. It is not available in the Google Play Store but is distributed through third-party app stores like CNET or Uptodown. According to publicly available information, VidMate was developed by a subsidiary of UC Web, which is owned by Chinese conglomerate Alibaba. Over a recent period Upst
Airship’s Data Study Reveals the State of Global Mobile Permissions One Year into GDPR22.5.2019 16:35:00 EEST | Tiedote
With GDPR reaching its one year anniversary May 25, customer engagement company Airship today revealed top-level results of its global benchmark study, examining the state of mobile app user permissions across nearly 700 million people worldwide. While marketers trimmed customer lists to meet new regulatory requirements for "traditional" channels (i.e., email), mobile app audiences continue to grow — up globally by +16.6 percent year over year. Businesses are also sending more notifications — averaging 36 per user per month (up 18.4 percent since last year) — while the average notification opt-in rate remains high at over two-thirds (67 percent) of global app users. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190522005486/en/ With mobile app audiences growing around the world, businesses are more heavily leveraging notifications with negligible impact to opt-in rates. (Graphic: Business Wire) These metrics vary at a regio
Diligent Launches Modern Governance to Address Dangerous Governance Deficits and Announces New Modern Governance Summit22.5.2019 16:27:00 EEST | Tiedote
Today, Diligent Corporation launched a new category, called modern governance, designed to provide leaders with the missing key to bring governance into the digital age, along with new technology and a summit to support this well-designed system. Modern governance is the practice of empowering leaders with technology, insights, and processes to fuel good governance that organizations require to thrive and endure. Modern governance helps organizations address governance deficits. A governance deficit means an organization lacks the security, foresight, and accountability to withstand the onslaught of contemporary challenges – such as activist investors, cyber risk, regulation, diversity and global uncertainty. Feedback from Diligent’s 16,000 clients and the 600,000 leaders who use its technology – including more than 50% of the Fortune 1000, 70% of the FTSE 100, and 65% of the ASX – sparked the need for rethinking how companies and their boards should approach governance to navigate tod
Wipro Builds a Blockchain-Based Solution for Travacoin to Enable Digital Currency-Based Payments for the Airline Industry22.5.2019 15:19:00 EEST | Tiedote
Wipro Limited (NYSE: WIT, BSE: 507685, NSE: WIPRO), a leading global information technology, consulting, and business process services company, today announced that it has developed a blockchain-based payment solution for Travacoin, a company specializing in an eponymous digital payment solution. Travacoin is a digital payment system which enables airlines to refund and compensate passengers in a timely manner when a disruption occurs. Passengers will be notified of a delay or cancellation and refunded in this digital currency, which can be used to repurchase airline tickets, book hotels and avail other airport and travel related services. Passengers will benefit by way of a significant reduction in the waiting time for compensation. In addition, passengers can use Travacoins at retail stores in and around the airport and avail attractive discounts offered by retail partners. By compensating passengers with Travacoins, airlines will be able to reduce their administrative overheads and
Uutishuoneessa voit lukea tiedotteitamme ja muuta julkaisemaamme materiaalia. Löydät sieltä niin yhteyshenkilöidemme tiedot kuin vapaasti julkaistavissa olevia kuvia ja videoita. Uutishuoneessa voit nähdä myös sosiaalisen median sisältöjä. Kaikki STT Infossa julkaistu materiaali on vapaasti median käytettävissä.Tutustu uutishuoneeseemme