Business Wire

Clovis Oncology Announces Availability of Rubraca®▼ (rucaparib) Tablets for Women with Relapsed Ovarian Cancer in Germany

Jaa

Clovis Oncology, Inc. (NASDAQ: CLVS) today announced that Rubraca ® (rucaparib) is now available by prescription in Germany as monotherapy for the maintenance treatment of adults with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy. In addition, Rubraca is indicated 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.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190304005368/en/

ARIEL3 Trial Fact Sheet

ARIEL3 Trial Fact Sheet

On January 24, 2019, the European Commission (EC) expanded rucaparib’s indication beyond its initial marketing authorization in Europe for the treatment of advanced ovarian cancer in selected patients granted in May 2018. With this label expansion, rucaparib is now approved as maintenance treatment for eligible patients regardless of their BRCA-mutation status. Rucaparib is the first PARP inhibitor licensed for an ovarian cancer treatment indication in the EU and is now the first to be available for both treatment and maintenance treatment among eligible patients.

“I have been treating women with relapsed ovarian cancer under the Rucaparib Access Program and I am confident that rucaparib represents an important treatment option for women here in Germany,” “said Professor Jalid Sehouli, Gynecologic Oncologist and head of the Charité European Competence Center for Ovarian Cancer at the University of Berlin. “There has been a significant need for additional treatment options for women with relapsed ovarian cancer, and rucaparib’s approval in the maintenance setting provides another option for these patients.”

“With this milestone approval in Germany, we are one step closer to ensuring that Rubraca is available to all eligible women who may potentially benefit,” said Patrick J. Mahaffy, President and CEO of Clovis Oncology. “Rubraca has shown further tumor shrinkage as well as prolonged progression-free survival in this maintenance setting, therefore Rubraca represents an important step forward for women with advanced ovarian cancer, regardless of their BRCA status.”

The EC authorization is 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.i

The ARIEL3 trial was a double-blind, placebo-controlled clinical trial of rucaparib that enrolled 564 women with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer in complete or partial response to platinum-based chemotherapy. Patients were randomized (2:1) to receive rucaparib tablets 600mg twice daily (n=375) or placebo (n=189). i

ARIEL3 successfully achieved its primary endpoint of extending investigator-assessed progression-free survival (PFS) versus placebo in all patients treated (intention-to-treat [ITT]), population, regardless of BRCA status (median 10.8 mos vs 5.4 mos); the key secondary endpoint of extending PFS as assessed by independent radiological review (IRR) was also achieved (median 13.7 mos vs 5.4 mos). ii

In a prespecified exploratory analysis of patients in the ITT population with measurable disease at baseline showed a tumor response was reported in 18 percent of patients (n=26) on rucaparib compared to eight percent of patients (n=5) on placebo, including seven percent (n=10) in the rucaparib group who achieved a complete remission. i

The overall safety profile of rucaparib is based on data from 937 patients with ovarian cancer treated with rucaparib monotherapy in clinical trials. Adverse reactions occurring in ≥20% of patients were nausea, fatigue/asthenia, vomiting, anemia, abdominal pain, dysgeusia, alanine aminotransferase (ALT) elevations, aspartate aminotransferase (AST) elevations, decreased appetite, diarrhea, thrombocytopenia and creatinine elevations. The majority of adverse reactions were mild to moderate (Grade 1 or 2). ii

Grade ≥3 adverse reactions occurring in >5% of patients were anemia (23%), ALT elevations (10%), fatigue/asthenia (10%), neutropenia (8%), thrombocytopenia (6%), and nausea (5%). The only serious adverse reaction occurring in > 2% of patients was anemia (5%). ii

Adverse reactions that most commonly led to dose reduction or interruption were anemia (20%), fatigue/asthenia (18%), nausea (16%), thrombocytopenia (15%), and AST/ALT elevations (10%). Adverse reactions leading to permanent discontinuation occurred in 10% of patients, with thrombocytopenia, nausea, anemia, and fatigue/asthenia being the most frequent adverse reactions leading to permanent discontinuation.ii

This release is only being distributed to members of the press and those health care practitioners allowed to receive prescription drug promotion.

About Ovarian Cancer in Europe and Germany

In 2018, ovarian cancer was the sixth most common cancer among women in Europe, with an estimated 68,000 women diagnosed and the fifth leading cause of cancer deaths among women, with an estimated 45,000 deaths annually. After initial therapy, many women’s disease will still recur, and approximately 70% of patients with ovarian cancer will relapse within the first three years following initial treatment. Germany has the highest incidence of new cases and deaths caused by ovarian cancer in Europe. The World Health Organization estimates that in 2018 there were approximately 6,800 new cases of ovarian cancer and 5,400 ovarian cancer-related deaths in the country.

About Rubraca ® (rucaparib)

Rucaparib is an oral, small molecule inhibitor of PARP1, PARP2 and PARP3 being developed in multiple tumor types, including ovarian, metastatic castration-resistant prostate, and bladder cancers, as monotherapy, and in combination with other anti-cancer agents. Exploratory studies in other tumor types are also underway.

Clovis holds worldwide rights for Rubraca. Rubraca is an unlicensed medical product outside of the U.S. and the EU.

Rubraca ® (rucaparib) EU Authorized Use and Important Safety Information

Rucaparib is indicated as monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy.

Rucaparib is indicated 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.

Summary warnings and precautions: Haematological toxicity: Patients should not start rucaparib until they have recovered from haematological toxicities caused by previous chemotherapy (≤ CTCAE Grade 1). Complete blood count testing prior to starting treatment with rucaparib and monthly thereafter is advised. Rucaparib should be interrupted or dose reduced, and blood counts monitored weekly until recovery for the management of low blood counts. Myelodysplastic syndrome/acute myeloid leukaemia (MDS/AML): If MDS/AML is suspected, the patient should be referred to a haematologist for further investigation. If MDS/AML is confirmed, rucaparib should be discontinued. Photosensitivity: Patients should avoid spending time in direct sunlight as they may burn more easily. When outdoors, patients should wear protective clothing and sunscreen with SPF of 50 or greater. Gastrointestinal toxicities: Low grade (CTCAE Grade 1 or 2) nausea and vomiting may be managed with dose reduction or interruption. Additionally, antiemetics may be considered for treatment or prophylaxis.

Click here to access the current Summary of Product Characteristics. Healthcare professionals should report any suspected adverse reactions via their national reporting systems.

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; please visit www.clovisoncology.com for more information, including additional office locations in the U.S. and Europe.

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. Examples of forward-looking statements contained in this press release include, among others, statements regarding our plans to launch Rubraca in additional European countries and to make Rubraca available to additional eligible patients. 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 the market potential of Rubraca, including the performance of our sales and marketing efforts and the success of competing drugs and therapeutic approaches, the performance of our third-party manufacturers, our clinical development programs for our drug candidates and those of our partners, and actions by the FDA, the EMA or other regulatory authorities regarding data required to support drug applications and whether to accept or approve drug applications that may be filed, as well as their decisions regarding drug labeling, reimbursement and pricing. 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 Coleman RL et al. Rucaparib maintenance treatment for recurrent ovarian carcinoma after response to platinum therapy (ARIEL3): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet 2017;390:1949-1961.

Ii Summary of Product Characteristics Rubraca 200, 250, 300 mg film-coated tablets. Clovis Oncology Inc. Last updated February 2019.

Contact information

Clovis Investor Contacts:
Anna Sussman, 303.625.5022
asussman@clovisoncology.com

Breanna Burkart, 303.625.5023
bburkart@clovisoncology.com

Clovis Media Contacts:
U.S.
Lisa Guiterman, 301.217.9353
clovismedia@sambrown.com

Christy Curran, 615.414.8668
clovismedia@sambrown.com

EU
Ann Hughes, +44 (0) 7956 700 790
Ann.Hughes@publicisresolute.com

Germany
Martin Kuegelgen +49 696 612 456 8332
Martin.Kuegelgen@mslgroup.com

Tietoja julkaisijasta

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

Earth Networks and RIMES Announce Technical Collaboration to Benefit Member Government Weather Services27.3.2019 02:00:00 EETTiedote

Earth Networks, a global provider of weather intelligence, announced today it has partnered with the Regional Integrated Multi-Hazard Early Warning System for Africa and Asia (RIMES). The partnership will enable a multi-year collaboration program to enhance RIMES’ member state National Hydro-Meteorological Services (NMHS) capacity for early warning of severe weather. The announcement was made at the 6th annual InterMET Asia conference in Singapore. Together, the two organizations are working to improve access to reliable weather information and early warning capabilities in Africa and Asia. By contributing on-the-ground insights from its weather and lightning networks, Earth Networks is providing critical hyperlocal data to RIMES to help regional NMHS close weather observation gaps in real-time and support more accurate forecasting. These technology enhancements will result in quicker warnings to the public before and during severe weather events. Earth Networks has years of experience

Huawei Rewrites the Rules of Photography with Groundbreaking HUAWEI P30 Series26.3.2019 19:04:00 EETTiedote

During an exclusive launch event today at the Paris Convention Center, Huawei Consumer Business Group (BG) unveiled the HUAWEI P30 and HUAWEI P30 Pro. The HUAWEI P30 Series builds on the HUAWEI P Series DNA in design and photography and is the company’s most advanced series of smartphone cameras. These devices feature the innovative HUAWEI SuperSpectrum Sensor, an optical SuperZoom Lens, a new HUAWEI Time of Flight (ToF) Camera, and enhanced optical and AI image stabilization technology. With these revolutionary technologies, the HUAWEI P30 and HUAWEI P30 Pro capture incredible photos and videos in every scenario. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190326005752/en/ HUAWEI P30 Series (Photo: Business Wire) Richard Yu, CEO of Huawei Consumer BG, said, “the HUAWEI P30 Series is a fundamental breakthrough after decades of digital camera technology development; it will rewrite the rules and reshape everyone’s percepti

Takeda Presents New Data at the Endocrine Society’s 2019 Annual Meeting about the Patient Burden and Long-Term Impact of Chronic Hypoparathyroidism26.3.2019 18:01:00 EETTiedote

Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (“Takeda”) this week shared new data revealing the burden of chronic hypoparathyroidism on patients and caregivers, as well as potential long-term risks of renal and cardiovascular complications that patients treated with conventional therapy may experience. Six-year results from the open-label long-term safety and efficacy RACE study were also announced. Data was presented at the Endocrine Society’s 2019 Annual Meeting (ENDO) from 23–26 March in New Orleans, Louisiana, USA. “Results from the Burden of Illness Global Survey in 13 countries reveal the extent of the impact hypoparathyroidism has on patients and their caregivers throughout their daily lives,” said John Bilezikian M.D., Professor of Medicine at the Columbia University Irving Medical Center, New York, NY, USA. “This offers important insights and enables us to take a more holistic approach in the management of these patients due to a greater understanding of the poten

LEO Pharma Standardizes on Veeva Development Cloud to Speed Drug Development26.3.2019 17:58:00 EETTiedote

Veeva Systems (NYSE:VEEV) today announced that LEO Pharma, a global leader in medical dermatology, selected Veeva Development Cloud applications to help drive end-to-end business processes across product development. The company will utilize the Vault Clinical, Vault RIM, and Vault Quality suites to unify drug development on a single cloud platform. With Veeva Development Cloud, LEO Pharma can bring together applications for clinical, regulatory, and quality for even greater efficiency and compliance throughout the product development lifecycle. “LEO Pharma R&D has embarked on an ambitious strategy for 2025, which will pave the way for our ambitions to continuously pioneer dermatology. This requires that we are able to drive science globally, whilst at the same time securing timely delivery on our pipeline,” said Kim Kjøller, executive vice president of global research and development at LEO Pharma. “Veeva Development Cloud gives us a unified platform that can enable us to maximize eff

Keio Plaza Hotel Tokyo Hosts Japanese Sword Culture, Armor Exhibition – “Japan’s Soul and Beauty of Swords and Armor by Legendary Artisans”26.3.2019 17:05:00 EETTiedote

Keio Plaza Hotel Tokyo (KPH), one of Japan’s most prestigious international hotels located in Shinjuku, Tokyo, will host a special exhibition entitled “Japan’s Soul and Beauty of Swords and Armor by Legendary Artisans” displaying beautiful Japanese swords and armor from April 25 (Thursday) to June 27 (Thursday), 2019 in the 3rd floor lobby of our Hotel. This exhibition is part of our series of cultural programs designed to introduce various aspects of Japanese culture to our guests visiting the Hotel from over 100 different countries around the world. Various precious and old swords and armor made during the Heian Period (794-1185) and other periods of Japanese history will be displayed, along with “tsuba” (Sword handle guards separating the handle from the blade) and other ornate sword fittings. On May 14, two masters of sword-drawing from Ryushin Shouchi School will give a live performance in the Main lobby from 5:00 p.m. This press release features multimedia. View the full release

Andersen Global Enters Qatar26.3.2019 16:30:00 EETTiedote

Andersen Global today announced a collaborating agreement in Qatar with Al-Khalifa Law, a leading Doha-based law firm. The collaboration is Andersen Global’s first in Qatar and is part of the organization’s continued growth in the Middle East. Al-Khalifa Law was founded 20 years ago and established itself as a premier firm in the region. The team at Al-Khalifa Law has diversified, deep experience providing services in a wide variety of business sectors, such as commercial contracts, taxation, employment, real estate and retail, intellectual property, dispute resolution and litigation and arbitration. “A collaboration with Andersen Global, which brings with it a culture of stewardship, transparency, and providing best-in-class services, was an obvious decision for us,” said Hamzeh Abdelhady, Office Managing Director of Al-Khalifa Law. “We will be able to continue providing quality services in the market and bring a premier, seamless association of experts throughout the world directly t

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