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AstraZeneca Mulls Broad Ovarian Cancer Maintenance Approval For Lynparza

 
• By Emily Hayes

Tesaro's niraparib has an advantage over other PARP inhibitors in that it has been tested successfully in Phase III for ovarian cancer patients with and without BRCA mutations, but AstraZeneca thinks it may have a case for broad labeling without pivotal data in this population.

AstraZeneca PLC thinks there is potential for its poly ADP-ribose polymerase (PARP) inhibitor Lynparza to get FDA approval as a maintenance therapy in ovarian cancer patients broadly, regardless of mutation status. But to do so, it will have to convince regulators to accept a "totality of the evidence" approach.

The company presented impressive data for Lynparza (olaparib) in the SOLO-2 study against placebo as a maintenance treatment in 295 relapsed patients with BRCA mutations on March 14 at the Society for Gynecologic Oncology (SGO) Annual Meeting on Women’s Cancer, held in National Harbor, Md. This followed a top-line release from the trial in October

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What The EMA Can Teach HTA Bodies About Joint Clinical Assessments

 
• By Francesca Bruce

EU-level joint clinical assessments conducted under the Health Technology Assessment Regulation need to be more flexible when it comes to evidence requirements, according to experts speaking at a gene and cell therapy conference.

EU ‘Can’t Expect Industry To Give Up Proprietary Insights’ Under Health Data & Clinical Trials Regulations

 
• By Eliza Slawther

Both the EU Clinical Trials Regulation and the European Health Data Space Regulation have the potential to improve harmonization and be highly valuable for industry – but the importance of protecting company data will be paramount, a life sciences consultant says.

UK Mandates Unmodified Standardized Contracts To Speed Clinical Trial Set-Up

 
• By Vibha Sharma

The policy expectation that the model clinical trial agreements are used without modification is in line requests from industry and the NHS/HSC.

DIA Korea: Medical Turmoil, Global Factors Blunt Korea’s Trial Edge

 
• By Jung Won Shin

DIA Korea hears how multiple domestic and global factors are affecting the environment for clinical trials in South Korea, and what actions may be taken to address this.

More from R&D

What The EMA Can Teach HTA Bodies About Joint Clinical Assessments

 
• By Francesca Bruce

EU-level joint clinical assessments conducted under the Health Technology Assessment Regulation need to be more flexible when it comes to evidence requirements, according to experts speaking at a gene and cell therapy conference.

EU ‘Can’t Expect Industry To Give Up Proprietary Insights’ Under Health Data & Clinical Trials Regulations

 
• By Eliza Slawther

Both the EU Clinical Trials Regulation and the European Health Data Space Regulation have the potential to improve harmonization and be highly valuable for industry – but the importance of protecting company data will be paramount, a life sciences consultant says.

How Tumult At US FDA Could Impact Merger and Acquisition Strategy

 
• By Joseph Haas and Nielsen Hobbs

With review and development uncertainly increasing, "it’s going to take longer for certain targets … to progress to a place where they’ve been derisked enough that big pharma is ready to write a big check," said Andrew Goodman of Paul Hastings.