Pharma Mar is betting on the Anglo-Saxon market. The Spanish drugmaker has submitted a conditional marketing authorization application for its product lurbinectedin to the UK’s Medicines and Healthcare products Regulatory Agency (Mhra). The application is for approval of Zepzelca (lurbinectedin) for treatment in adult patients with metastatic small-cell lung cancer who have progressed after prior platinum-based chemotherapy, the group said in a statement sent to the Spanish Securities and Exchange Commission (Comisión Nacional del Mercado de Valores, Cnmv).
Read more about Pharma Mar and its lung cancer treatment and find the latest business headlines of the day with teh Born2invets mobile app.
The company has developed and currently markets Yondelis in Europe, as well as Zepzelca (lurbinectedin) in the United States
This registration application is based on data from the Phase II basket trial with lurbinectedin, in monotherapy, for the treatment of small-cell lung cancer. This is the same trial that was used for conditional approval of lurbinectedin in the United States for the same indication and whose results were presented at the American Society of Clinical Oncology (Asco) congress in June 2019. Pharma Mar advances against metastatic small-cell lung cancer Lurbinectedin received accelerated approval from the US Food and Drug Administration (FDA) in June 2020 for the treatment of adult patients with metastatic small-cell lung cancer with disease progression and is already the standard of care in the US. In 2021, lurbinectedin also received marketing authorization in the United Arab Emirates (UAE), Canada, Australia, and Singapore.
According to regulations, an accelerated authorization requires a confirmatory trial, so Pharma Mar announced in December 2021 the start of a confirmatory Phase III clinical trial, Lagoon, evaluating lurbinectedin for the treatment of patients with recurrent small-cell lung cancer, which will also be used to apply for registration in Europe.
Pharma Mar is a pharmaceutical company focused on research and development of new cancer treatments. The company has developed and currently markets Yondelis in Europe, as well as Zepzelca (lurbinectedin) in the United States and Aplidin (plitidepsin) in Australia, with different partners. Headquartered in Madrid, Pharma Mar has subsidiaries in Germany, France, Italy, Belgium, Austria, Switzerland, and the United States. Pharma Mar is also majority-owned by other companies: Genomica, a Spanish company in the field of molecular diagnostics, and Sylentis, which researches therapeutic applications of gene silencing (RNAi).
DISCLAIMER: This article was written by a third party contributor and does not reflect the opinion of Born2Invest, its management, staff or its associates. Please review our disclaimer for more information.
This article may include forward-looking statements. These forward-looking statements generally are identified by the words “believe,” “project,” “estimate,” “become,” “plan,” “will,” and similar expressions. These forward-looking statements involve known and unknown risks as well as uncertainties, including those discussed in the following cautionary statements and elsewhere in this article and on this site. Although the Company may believe that its expectations are based on reasonable assumptions, the actual results that the Company may achieve may differ materially from any forward-looking statements, which reflect the opinions of the management of the Company only as of the date hereof. Additionally, please make sure to read these important disclosures.
First published in PlantaDoce, a third-party contributor translated and adapted the article from the original. In case of discrepancy, the original will prevail.
Although we made reasonable efforts to provide accurate translations, some parts may be incorrect. Born2Invest assumes no responsibility for errors, omissions or ambiguities in the translations provided on this website. Any person or entity relying on translated content does so at their own risk. Born2Invest is not responsible for losses caused by such reliance on the accuracy or reliability of translated information. If you wish to report an error or inaccuracy in the translation, we encourage you to contact us.
The TopRanked.io Weekly Digest: What’s Hot in Affiliate Marketing [Buffalo Partners]
First, they came for your college campuses. Then they came for your news, your politics, and you entertainment. And now,...
Redeban Boosts its Leadership in Colombia with the Acquisition of SoyYo
The SoyYo brand will be maintained and enters Redeban's portfolio as one of its strategic units. SoyYo is a recognized...
Why the Growth of Real Estate Crowdfunding in Mexico Slows in 2023
An amount that could make real estate crowdfunding more attractive is 500 million pesos or more. Likewise, he added that...
Biomedical Companies in Spain Demand Tax Incentives for R&D Adapted to the Reality of the Sector
There are many companies in the biomedical sector that, being in the investment or expansion phase, have negative or reduced...
Switzerland Will Probably Legalize Cannabis in the Next Four Years
Switzerland has the advantage that it has already introduced legalization tests in various municipalities. Each test can cover up to...
Markets5 days ago
A Look at the Vibrant Inflation and Slowing Economy in the US
Biotech2 weeks ago
Eight Out of Ten Spanish Companies in the Biotech Sector Increase R&D Investment
Crypto3 days ago
SMOG: Experts Name the Flagship Crypto of the Solana Ecosystem
Crypto1 week ago
IOTA Is Developing a Solution for KYC Identity Verification on Web3 with Four Partners