European Medicines Agency Accepts Astellas’ Marketing Authorization Application for Zolbetuximab

TOKYO – WEBWIRE

Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, Astellas) today announced the European Medicines Agency (EMA) has accepted for regulatory review the companys marketing authorization application (MAA) for zolbetuximab, a first-in-class investigational Claudin 18.2 (CLDN18.2)-targeted monoclonal antibody, for first-line treatment of patients with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors are CLDN18.2-positive. If approved, zolbetuximab would be the first CLDN18.2-targeted therapy available in Europe for these patients.

Gastric cancer accounted for 3.1% of all new cancer cases in Europe in 2020, with around 136,000 new cases diagnosed.1 The average five-year survival rate for patients with gastric cancer in Europe is 26% across all stages.2

Patients with gastric cancer in Europe face extremely low five-year survival rates regardless of their disease stage, and innovative therapies that extend survival are needed, said Moitreyee Chatterjee-Kishore, PhD, MBA, Senior Vice President and Head of Immuno-Oncology Development, Astellas. The EMAs acceptance of the zolbetuximab MAA continues a cascade of regulatory milestones for Astellas that are aimed at bringing a new option to patients with advanced gastric and GEJ cancer.

The MAA is based on results from the Phase 3 SPOTLIGHT and GLOW clinical trials. The SPOTLIGHT study evaluated zolbetuximab plus mFOLFOX6 (a combination regimen that includes oxaliplatin, leucovorin and fluorouracil) compared to placebo plus mFOLFOX6. The GLOW study evaluated zolbetuximab plus CAPOX (a combination chemotherapy regimen that includes capecitabine and oxaliplatin) compared to placebo plus CAPOX.

In both SPOTLIGHT and GLOW, approximately 38% of patients screened for the trials had tumors that were CLDN18.2-positive (≥75% of tumor cells with moderate-to-strong membranous CLDN18 staining intensity), as determined by a validated immunohistochemistry assay.3,4

The anticipated recommendation by the Committee for Medicinal Products for Human Use (CHMP) of the EMA regarding the MAA and subsequent European Commission (EC) decision are expected in calendar year 2024.

Astellas has already reflected the impact from this acceptance in its financial forecast of the current fiscal year ending March 31, 2024.

Click below for a copy of the full press release

European Medicines Agency Accepts Astellas Marketing Authorization Application for Zolbetuximab

GSMA And European Space Agency Launch New Communications Innovation Partnership

New Collaboration Will Look to Accelerate Advancements in Satellite and Terrestrial Communications Network Integration

OXFORDSHIRE – WEBWIRE

The GSMA and European Space Agency (ESA) signed a Memorandum of Intent (MOI) to bring the mobile and satellite industries closer together to collaborate on developing new, innovative satellite and terrestrial networks technologies.

The ambition of the partnership is to further strengthen the competitiveness of both mobile and satellite network industries, by creating an ecosystem which can fast-track the development of new complimentary technology solutions for businesses and consumers. The two organisations will join efforts to speed-up innovation when it comes to integrating satellite communications with 5G and future 6G networks.

Key to this collaboration will be the GSMA Foundry innovation accelerator which brings together the mobile network operator community, and the wider technology industry, to accelerate cross-industry collaboration and advancements in mobile communication. As the Home of Mobile Innovation, GSMA Foundry helps members forge the digital future by rapidly developing real-world solutions to industry challenges, nurture innovative ideas through initial commercial trials, and scale proven solutions at a regional and global level.

GSMA Foundry will work closely with ESAs 5G/6G Hub, based at ESAs European Centre for Space Applications and Telecommunications (ECSAT) based in Harwell, Oxfordshire. The ESA Hub brings together the satellite industry to work on new collaborative and innovative programmes. Benefiting from the support of the UK Space Agency (UKSA) the Hub fits into the UK Governments 5G and 6G strategy.

As part of the MOI, the GSMA and ESA aim to collaborate and share knowledge, ideas, and outcomes of trials, which can help better integrate 5G and future 6G communications with non-terrestrial networks. This will be done through joint GSMA Foundry and ESA technology challenges supporting terrestrial and non-terrestrial networks, as well as through joint events and promotions at conferences, such as Mobile World Congress.

To bring added support to the partnership, GSMA Intelligence (GSMAi) will add research and insights on key focus topics.

Recent research findings by GSMAi showed that the increased adoption and integration of satellite technologies by the communications industry could lead to potential revenue gains of $35bn by 2035 (a 3% uplift on telecommunications industry revenues).

Speaking following the signing of the MOI at ECSAT in Oxfordshire, Alex Sinclair, Chief Technology Officer at the GSMA said: By collaborating more closely with the European Space Agency, and its satellite network operator ecosystem, we hope to accelerate the immense potential satellite and terrestrial telecommunications networks can create for consumers and businesses when they are more closely connected. By working together, we can help the communications industry bring innovative solutions to market, which in turn will create tremendous benefits to society by connecting even more people, wherever they are in the world.

Antonio Franchi, Head of Space for 5G and 6G Strategic Programme, ESA, said: Collaboration is key to telecommunications innovation and, from our 5G/6G Hub, we are fostering industry partnerships to advance the 5G digital transformation of society and industry. We look forward to working with GSMA to explore and realise the huge potential of next-generation satellite-enabled connectivity.

About GSMA
The GSMA is a global organisation unifying the mobile ecosystem to discover, develop and deliver innovation foundational to positive business environments and societal change. Our vision is to unlock the full power of connectivity so that people, industry, and society thrive. Representing mobile operators and organisations across the mobile ecosystem andadjacent industries, the GSMA delivers for its members across three broad pillars: Connectivity for Good, Industry Services and Solutions, and Outreach. This activity includes advancing policy, tackling todays biggest societal challenges, underpinning the technology and interoperability that make mobile work, and providing the worlds largest platform to convene the mobile ecosystem at the MWC and M360 series of events.

We invite you to find out more at gsma.com

For more information on GSMA Foundry, please visit: gsma.com/foundry

About the European Space Agency
The European Space Agency (ESA) provides Europes gateway to space.
ESA is an intergovernmental organisation, created in 1975, with the mission to shape the development of Europes space capability and ensure that investment in space delivers benefits to the citizens of Europe and the world.

ESA has 22 Member States: Austria, Belgium, the Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Luxembourg, the Netherlands, Norway, Poland, Portugal, Romania, Spain, Sweden, Switzerland and the United Kingdom. Slovenia, Latvia and Lithuania are Associate Members.

ESA has established formal cooperation with five Member States of the EU. Canada takes part in some ESA programmes under a Cooperation Agreement.

By coordinating the financial and intellectual resources of its members, ESA can undertake programmes and activities far beyond the scope of any single European country. It is working in particular with the EU on implementing the Galileo and Copernicus programmes as well as with Eumetsat for the development of meteorological missions.

Learn more about ESA at www.esa.int

Data Protection: European Commission adopts new adequacy decision for safe and trusted EU-US data flows

Brussels – WEBWIRE

An adequate protection of our personal data is a fundamental right, and one whose importance only continues to grow in our day-to-day lives.

The European Commission adopted its adequacy decision for the EU-U.S. Data Privacy Framework. The decision concludes that the United States ensures an adequate level of protection comparable to that of the European Union for personal data transferred from the EU to US companies under the new framework. On the basis of the new adequacy decision, personal data can flow safely from the EU to US companies participating in the Framework, without having to put in place additional data protection safeguards.

The EU-U.S. Data Privacy Framework introduces new binding safeguards to address all the concerns raised by the European Court of Justice, including limiting access to EU data by US intelligence services to what is necessary and proportionate, and establishing a Data Protection Review Court (DPRC), to which EU individuals will have access. The new framework introduces significant improvements compared to the mechanism that existed under the Privacy Shield. For example, if the DPRC finds that data was collected in violation of the new safeguards, it will be able to order the deletion of the data. The new safeguards in the area of government access to data will complement the obligations that US companies importing data from EU will have to subscribe to.

President Ursula von der Leyen said: The new EU-U.S. Data Privacy Framework will ensure safe data flows for Europeans and bring legal certainty to companies on both sides of the Atlantic.Following the agreement in principle I reached with President Biden last year, the US has implemented unprecedented commitments to establish the new framework.Today we take an important step to provide trust to citizens that their data is safe, to deepen our economic ties between the EU and the US, and at the same time to reaffirm our shared values. It shows that by working together, we can address the most complex issues.

US companies will be able to join the EU-U.S. Data Privacy Framework by committing to comply with a detailed set of privacy obligations, for instance the requirement to delete personal data when it is no longer necessary for the purpose for which it was collected, and to ensure continuity of protection when personal data is shared with third parties.

EU individuals will benefit from several redress avenues in case their data is wrongly handled by US companies. This includes free of charge independent dispute resolution mechanisms and an arbitration panel.

In addition, the US legal framework provides for a number of safeguards regarding the access to data transferred under the framework by US public authorities, in particular for criminal law enforcement and national security purposes. Access to data is limited to what is necessary and proportionate to protect national security.

EU individuals will have access to an independent and impartial redress mechanism regarding the collection and use of their data by US intelligence agencies, which includes a newly created Data Protection Review Court (DPRC). The Court will independently investigate and resolve complaints, including by adopting binding remedial measures.

The safeguards put in place by the US will also facilitate transatlantic data flows more generally, since they also apply when data is transferred by using other tools, such as standard contractual clauses and binding corporate rules.

Next steps

The functioning of the EU-U.S. Data Privacy Framework will be subject to periodic reviews, to be carried out by the European Commission, together with representatives of European data protection authorities and competent US authorities.

The first review will take place within a year of the entry into force of the adequacy decision, in order to verify that all relevant elements have been fully implemented in the US legal framework and are functioning effectively in practice.

Background

Article 45(3) of the General Data Protection Regulation (GDPR) grants the Commission the power to decide, by means of an implementing act, that a non-EU country ensures an adequate level of protection – a level of protection for personal data that is essentially equivalent to the level of protection within the EU. The effect of adequacy decisions is that personal data can flow freely from the EU (and Norway, Liechtenstein and Iceland) to a third country without further obstacles.

After the invalidation of the previous adequacy decision on the EU-U.S. Privacy Shield by the Court of Justice of the EU, the European Commission and the US governmententered into discussionson a new framework that addressed the issues raised by the Court.

In March 2022, President von der Leyen and President Biden announced that they had reached an agreement in principle on a new transatlantic data flows framework, following negotiations between CommissionerReyndersand US Secretary Raimondo. In October 2022, President Biden signed an Executive Order on Enhancing Safeguards for United States Signals Intelligence Activities, which was complemented by regulations issued by US Attorney General Garland. Together, these two instruments implemented the US commitments reached under the agreement in principle into US law, and complemented the obligations for US companies under the EU-U.S. Data Privacy Framework.

An essential element of the US legal framework enshrining these safeguards is the US Executive Order on Enhancing Safeguards for United States Signals Intelligence Activities, which addresses the concerns raised by the Court of Justice of the European Union in itsSchrems IIdecision of July 2020.

The Framework is administered and monitored by the US Department of Commerce. The US Federal Trade Commission will enforce US companies compliance.

For More Information

Adequacy decision on the EU-US Data Privacy Framework

Questions and Answers : EU US Data Privacy Framework

Factsheet Transatlantic Data Privacy Framework

EU-US data transfers (europa.eu)

International dimension of data protection (europa.eu)

Adequacy decisions (europa.eu)

Joint Statement on Trans-Atlantic Data Privacy Framework (europa.eu)

Quote(s)

An adequate protection of our personal data is a fundamental right, and one whose importance only continues to grow in our day-to-day lives. Todays decision is the result of intense cooperation with our partners in the US, working together to ensure that Europeans data travels safely, wherever it goes. The new adequacy decision will provide legal certainty for businesses and will help further consolidate the EU as a powerful player in transatlantic markets, while remaining uncompromising on respecting fundamental right of Europeans for their data to be always protected.

Věra Jourov, Vice-President for Values and Transparency – 10/07/2023

The adoption of this adequacy decision is the final step to ensure safe and free transfers of data across the Atlantic. It ensures the protection of individual rights in our intangible and interconnected digital world, where physical borders do not matter much anymore. Since the Schrems II decision came out years ago, I have worked tirelessly with my US counterparts to address the concerns identified by the Court of Justice, and ensure that technological advances do not come at the cost of Europeans trust. But as close like-minded-partners, the EU and the US could find solutions, based on their shared values, that are both lawful and workable in their respective systems.

Didier Reynders, Commissioner for Justice – 10/07/2023

Canada – Minister Ng speaks with European Commission Executive Vice-President and European Union Commissioner for Trade 

Yesterday, the Honourable Mary Ng, Minister of International Trade, Export Promotion, Small Business and Economic Development, met virtually with Valdis Dombrovskis, European Commission Executive Vice-President and European Union Commissioner for Trade.

January 19, 2022 – Ottawa, Canada – Global Affairs Canada

Yesterday, the Honourable Mary Ng, Minister of International Trade, Export Promotion, Small Business and Economic Development, met virtually with Valdis Dombrovskis, European Commission Executive Vice-President and European Union Commissioner for Trade.

Minister Ng extended her appreciation of the EU’s ongoing engagement in the Ottawa Group and support to advance work on WTO reform priorities. The ministers agreed to continue the momentum to address key issues, including trade and health, fisheries subsidies negotiations, agriculture negotiations, and WTO reform.

Minister Ng and Minister Dombrovskis committed to further strengthen bilateral commercial relations, including the full implementation of the Canada-European Union Comprehensive Economic and Trade Agreement. Minister Ng also discussed the importance of working together to address trade-distorting subsidies while also avoiding the creation of new barriers to trade and investments between Canada and the EU.

Associated links

Minister Ng receives assurances from European Commissioner for Trade Valdis Dombrovskis about vaccine exports to Canada
Canada-EU bilateral relations 
Minister Ng hosts final Ottawa Group meeting of 2021
Canada and the WTO
Ottawa Group and WTO reform

Alice Hansen

Press Secretary

Office of the Minister of International Trade, Export Promotion, Small Business and Economic Development

613-612-0482

Alice.Hansen@international.gc.ca

Japan – European Commission Approves LENVIMA (lenvatinib) Plus KEYTRUDA (pembrolizumab) for Patients With Certain Types of Endometrial Carcinoma

Eisai Co., Ltd. and Merck & Co., Inc., Kenilworth, N.J., U.S.A. (known as MSD outside the United States and Canada) today announced that the European Commission has approved the combination of LENVIMA, the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai, plus KEYTRUDA, the anti-PD-1 therapy from Merck & Co., Inc., Kenilworth, N.J., U.S.A., for the treatment of advanced or recurrent endometrial carcinoma in adults who have disease progression on or following prior treatment with a platinum containing therapy in any setting and who are not candidates for curative surgery or radiation. This marks the first combination of tyrosine kinase inhibitor with immunotherapy approved in Europe for these patients with advanced or recurrent endometrial carcinoma.

The approval is based on results from the pivotal Phase 3 Study 309/KEYNOTE-775 trial, in which LENVIMA plus KEYTRUDA demonstrated statistically significant improvements in overall survival (OS), reducing the risk of death by 38% (HR=0.62 [95% CI, 0.51-0.75]; p
“This approval is welcome news for patients in Europe, and is based on the first Phase 3 study evaluating an immunotherapy and tyrosine kinase inhibitor combination that showed superior overall survival for patients with advanced or recurrent endometrial cancer compared to chemotherapy,” said Dr. Gregory Lubiniecki, Vice President, Clinical Research, Merck & Co., Inc., Kenilworth, N.J., U.S.A. Research Laboratories. “Regardless of mismatch repair status, patients whose endometrial cancer progresses or returns after prior platinum-containing systemic therapies now have a combination treatment option in KEYTRUDA plus LENVIMA that demonstrated a 38% reduction in risk of death compared to chemotherapy alone.”

“Until recently, women in Europe with advanced or recurrent endometrial cancer have faced a difficult prognosis and had few treatment options,” said Corina Dutcus, M.D., Vice President, Clinical Research, Oncology Business Group at Eisai Inc. “The approval of LENVIMA plus KEYTRUDA in this setting reflects the progress that we have made in our collaboration with Merck & Co., Inc., Kenilworth, N.J., U.S.A. in developing solutions for those diagnosed with difficult-to-treat cancers. We thank the patients, families and healthcare providers who made this milestone possible.”

In the Study 309 trial, the most common adverse reactions of these patients (>/=20%) for LENVIMA plus KEYTRUDA* were hypertension (63%), diarrhoea (57%), hypothyroidism (56%), nausea (51%), decreased appetite (47%), vomiting (39%), fatigue (38%), decreased weight (35%), arthralgia (33%), proteinuria (29%), constipation (27%), headache (27%), urinary tract infection (27%), dysphonia (25%), abdominal pain (23%), asthenia (23%), palmar-plantar erythrodysaesthesia syndrome (23%), stomatitis (23%), anaemia (22%), and hypomagnesaemia (20%).

This approval allows marketing of LENVIMA plus KEYTRUDA in all 27 EU member states plus Iceland, Liechtenstein, Norway and Northern Ireland. LENVIMA plus KEYTRUDA is now approved by the European Commission for two different types of cancer: for advanced or recurrent endometrial carcinoma in adults who have disease progression on or following prior treatment with a platinum containing therapy in any setting and who are not candidates for curative surgery or radiation and for the first-line treatment of adult patients with advanced renal cell carcinoma.

*According to the information listed in the SmPC (Summary of Product Characteristics)

For more information, visit https://www.eisai.com/news/2021/news202193.html.

Copyright ©2021 JCN Newswire. All rights reserved. A division of Japan Corporate News Network.