Eli Lilly says it will not seeking approval for its much-touted drug ramucirumab in breast cancer after it failed in a late-stage trial, but a Phase III study in gastric cancer proved more successful.
Most attention was on the breast cancer findings, which compared ramucirumab and docetaxel to placebo and docetaxel as a first-line treatment in patients with unresectable, locally recurrent or metastatic HER2-negative breast cancer. The primary endpoint of progression-free survival in this study favoured the Lilly drug but was not statistically significant, while an interim analysis for overall survival showed no benefit.
Lilly says it does not plan to submit an application to regulatory authorities for ramucirumab for the breast cancer indication. John Mackey, principal investigator of the study and professor of oncology at the University of Alberta, noted that “unfortunately, anti-angiogenic agents have not yet been able to demonstrate an overall survival benefit for patients with metastatic breast cancer”.
On a brighter note, a Phase III study of ramucirumab in combination with paclitaxel in patients with advanced gastric cancer met its primary endpoint of improved overall survival and a secondary endpoint of improved progression-free survival. This is the second successful late-stage trial demonstrating an improvement in both overall and progression-free survival and filings will be submitted soon.
Source: Pharma Times
Novartis and Malaria No More announced today the debut of the Power of One campaign, encouraging people around the world to help end child deaths from malaria. Novartis will support the campaign financially and donate up to three million Coartem® Dispersible treatments to match antimalarials funded by the public. The company’s commitment to Power of One aligns with its long history in the fight against malaria; the Novartis Malaria Initiative is one of the largest access-to-medicine programs in the healthcare industry.
Malaria is a preventable and treatable disease, but it still kills a child every minute. It is estimated that over 300 million additional treatments will be needed to treat malaria patients across Africa between now and the end of 2015. The Power of One campaign aims to address this treatment gap through direct donations and existing government commitments. Every dollar donated to the campaign will buy and deliver a treatment to a child diagnosed with malaria.
Source: World Pharma News
Boehringer Ingelheim today announces new milestones for the novel oral anticoagulant Pradaxa® (dabigatran etexilate) with over two million patient-years of experience in all licensed indications globally.1 In addition the company confirms research currently underway for Pradaxa® in new cardiovascular patient populations as well as robust plans to gather real-world evidence in patients with non-valvular atrial fibrillation (NVAF). These plans are the cornerstone of an initiative to expand the scientific knowledge of stroke prevention and interventional cardiology with Pradaxa® and demonstrate Boehringer Ingelheim’s leadership and commitment to innovative solutions for patients and healthcare providers.
Initiating new research will help strengthen understanding of the safety and efficacy profile of Pradaxa® the longest studied novel oral anticoagulant (NOAC). Since its discovery 20 years ago Pradaxa® has been evaluated through the extensive RE-VOLUTION® clinical trial programme which includes 10 clinical trials involving more than 40000 patients in over 100 countries globally.2-12
“We are building upon Pradaxa®’s strong foundation in clinical research and prescribing experience to deepen our understanding of the treatment’s benefit/risk profile to address evolving patient needs and benefit the cardiovascular community as a whole” commented Professor Klaus Dugi Corporate Senior Vice President Medicine Boehringer Ingelheim. “Now we are in discussions regarding plans for important new clinical trials where we see unmet patient need. Details of these plans will be announced in the near future.”