Bayer bags US approval for liver cancer treatment

Bayer has gained US FDA approved for Stivarga tablets for the second-line treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with Nexavar.

Regorafenib is the first and only treatment to demonstrate significant improvement in overall survival in second-line HCC patients.

Regorafenib is an oral inhibitor of multiple kinases involved in normal cellular functioning and in pathological processes such as oncogenesis, tumour angiogenesis, metastasis and tumour immunity.

The FDAs approval is based on data from the international, multicenter, placebo-controlled Phase III Resorce trial, which investigated patients with HCC whose disease had progressed during treatment with sorafenib.

Hepatocellular carcinoma is very hard to treat, and with no new licensed treatments in nearly a decade, options have been very limited for physicians and patients, said Dr Jordi Bruix, lead investigator for the Resorce trial, BCLC Group, Liver Unit, Hospital Clinic, University of Barcelona.

The approval of regorafenib for hepatocellular carcinoma therefore provides a significant step forward in addressing the high unmet need in this patient population.

The incidence of liver cancer is increasing worldwide and it is already the sixth most common cancer in the world and the second leading cause of cancer-related deaths globally.

The approval of regorafenib in liver cancer marks the third time that this therapy has been granted FDA approval on a priority basis.

The FDA granted Fast Track designation to regorafenib in HCC, which is an expedited program designed to facilitate development and review of drugs to address an unmet medical need in the treatment of a serious or life-threatening condition.

Additional regulatory filings for regorafenib in HCC are under review in countries around the world, including the European Union, Japan and China.

Decisions in the EU and Japan regions are expected later this year.

A message from the Editor:

Thank you for reading this story on our news site - please take a moment to read this important message:

As you know, our aim is to bring you, the reader, an editorially led news site but journalism costs money and we rely on advertising and digital revenues to help to support them.

With the Covid-19 lockdown having a major impact on our industry as a whole, the advertising revenues we normally receive, which helps us cover the cost of our journalists and this website, have been drastically affected.

As such we need your help. If you can support our news sites with a small donation of even £1, your generosity will help us weather the storm and continue in our quest to deliver quality journalism.

In the meantime may I wish you the very best.

- Advertisement -

Sanofi & Translate Bio expand collaboration to develop mRNA vaccines

Sanofi Pasteur, the vaccines global business unit of Sanofi, and Translate Bio, a clinical-stage messenger RNA (mRNA) therapeutics company, are expanding their existing 2018...

Sarepta & Codiak to research, develop exosome-based therapeutics

Precision medicine specialist, Sarepta Therapeutics, and Codiak BioSciences, a company at the forefront of advancing engineered exosomes as a new class of biologic medicines,...

Gilead acquires equity interest in pioneering immunotherapy company

Gilead Sciences is acquiring a 49.9% equity interest in Pionyr Immunotherapeutics, a privately held San Fran company developing first-in-class cancer immunotherapies. The acquisition – for...

New class of precision medicine strips cancer of its DNA defences

A new precision medicine targeting cancer’s ability to repair its DNA has shown promising results in the first clinical trial of the drug class. The...

Tonix & Southern Research expand COVID-19 vaccine collaboration to include T cell study

New York biopharma, Tonix Pharmaceuticals, has expanded its strategic collaboration with Southern Research to include a study of T cell immune responses to SARS-CoV-2...

Related news

Avalon GloboCare & BOKU to advance intranasal & oral COVID-19 vaccine candidate

Avalon GloboCare, a New Jersey-based clinical-stage global developer of cell-based technologies and therapeutics, has partnered with the University of Natural Resources and Life Sciences...

Sanofi & Translate Bio expand collaboration to develop mRNA vaccines

Sanofi Pasteur, the vaccines global business unit of Sanofi, and Translate Bio, a clinical-stage messenger RNA (mRNA) therapeutics company, are expanding their existing 2018...

Sarepta & Codiak to research, develop exosome-based therapeutics

Precision medicine specialist, Sarepta Therapeutics, and Codiak BioSciences, a company at the forefront of advancing engineered exosomes as a new class of biologic medicines,...

Gilead acquires equity interest in pioneering immunotherapy company

Gilead Sciences is acquiring a 49.9% equity interest in Pionyr Immunotherapeutics, a privately held San Fran company developing first-in-class cancer immunotherapies. The acquisition – for...