A promising new class of drugs is proving powerful in the fight against ovarian cancer. The race to create the next potent ovarian cancer drug is coming to a head. In recent days, the researchers behind three PARP drug contenders threw down preliminary data during the European Society for Medical Oncology conference in Denmark. Massachusetts-based Tesaro was the clear front-runner with its experimental once-a-day ovarian cancer pill, niraparib. Its results built upon exciting data it released in June -- showing that its drug can increase the window of time in which a woman's cancer doesn't get worse.
AstraZeneca today announced positive overall survival (OS) results from the Phase III FLAURA trial, a randomised, double-blinded, multi-centre trial of Tagrisso (osimertinib) in previously-untreated patients with locally-advanced or metastatic non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) mutations. Tagrisso showed a statistically-significant and clinically-meaningful improvement in OS, a secondary endpoint in the FLAURA Phase III trial, compared with erlotinib or gefitinib both of which were previous standard-of-care (SoC) treatments in this setting. The FLAURA trial met its primary endpoint in July 2017, showing a statistically-significant and clinically-meaningful improvement in progression-free survival (PFS), increasing the time patients lived without disease progression or death from any cause. The safety and tolerability of Tagrisso was consistent with its established profile. José Baselga, Executive Vice President, Oncology R&D said: "Today's positive results show that Tagrisso provides an unprecedented survival outcome versus previous standard-of-care epidermal growth factor receptor tyrosine kinase inhibitors, reaffirming Tagrisso as the 1st-line standard-of-care for EGFR-mutated metastatic non-small cell lung cancer."
Drugs are scoring big wins against common cancers, setting new standards for how to treat many prostate, breast and lung tumors. There's even a'uni-drug' that may fight many forms of the disease. What's striking: The drugs are beneficial in some cases for more than a year, much longer than the few months many new drugs provide. Here are highlights from the world's largest cancer meeting, the American Society of Clinical Oncology conference in Chicago. Janssen Biotech's Zytiga improved survival and delayed cancer growth for 18 months when added to standard care in a study of 1,200 men with advanced prostate cancer.
AstraZeneca today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for Calquence (acalabrutinib) as a monotherapy treatment for adult patients with chronic lymphocytic leukaemia (CLL), one of the most common types of leukaemia in adults.1 José Baselga, Executive Vice President, Oncology R&D, said: "This is an important regulatory milestone for our work in haematology and for patients living with chronic lymphocytic leukaemia, a life-threatening disease. The Breakthrough Therapy Designation acknowledges the growing body of evidence that supports Calquence as a highly-selective Bruton tyrosine kinase inhibitor with the potential to offer patients a new, differentiated, chemotherapy-free treatment option with a favourable safety profile." The FDA granted the BTD based on positive results from the interim analyses of the ELEVATE-TN and ASCEND Phase III clinical trials. Together the trials showed that Calquence alone or in combination significantly increased the time patients lived without disease progression or death, with safety and tolerability that was consistent with its established profile. This is the 10th BTD that AstraZeneca has received from the FDA since 2014.
LONDON – An experimental AstraZeneca drug that failed last year as a treatment for a rare cancer of the eye has been awarded special "orphan" status in the United States for a type of thyroid cancer. The British drugmaker, which is relying on cancer treatments to revive its fortunes following a wave of patent expiries, said on Thursday the decision showed the potential importance of selumetinib for some patients. Orphan status is awarded to medicines promising significant benefit in treating rare, life-threatening diseases and the designation provides companies with special development and market exclusivity incentives. AstraZeneca's drug is being tested for patients with advanced differentiated thyroid cancer who fail to respond adequately to radioactive iodine. Selumetinib, which belongs to a class of cancer drugs known as MEK inhibitors, failed to meet its goal in a late-stage trial for uveal melanoma in July 2015.