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Ibrutinib Submitted to FDA for Treatment of Marginal Zone Lymphoma The FDA received a supplemental new drug application ( sNDA ) for ibrutinib for the treatment of marginal zone lymphoma ( MZL ). If approved , it could become the first treatment with a specific indication for this rare disease . MZL accounts for 12 percent of all cases of non-Hodgkin lymphoma in adults .
The sNDA is based on data from the international , multicenter , open-label , phase II PCYC-1121-CA trial , which assessed the use of single-agent ibrutinib in patients with MZL – including splenic MZL , nodal MZL , and extranodal MZL – who had received at least one prior therapy .
Patients received 560 mg of ibrutinib orally once daily until progression or unacceptable toxicity . The study ’ s primary endpoint is overall response rate ( ORR ), as determined by an independent review committee . Secondary endpoints include duration of response and overall survival . Outcomes have not yet been reported .
Ibrutinib previously was approved by the FDA for the treatment of patients with mantle cell lymphoma , chronic lymphocytic leukemia / small lymphocytic leukemia , and Waldenström macroglobulinemia .
Source : Janssen press release , September 26 , 2016 .
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ASH Releases Statement on Congressional Funding ASH released a statement from President Charles S . Abrams , MD , congratulating Congress on the passage of a short-term resolution to fund the NIH and other federal programs through December 9 . ASH also applauds the inclusion of emergency supplemental funding for public health emergencies such as Zika virus . However , the Society remains concerned about the ongoing impact that limited funding extensions have on medical advancements that are dependent upon sustained and predictable support .
“ Last year , Congress showed a strong bipartisan commitment to support biomedical research by providing a $ 2 billion increase for NIH in fiscal year ( FY ) 2016 ,” ASH representatives wrote in the news release . “ Yet , if the nation is to continue to accelerate the development of life-changing cures , pioneering treatments , and innovative prevention strategies , it is essential for Congress to maintain this commitment .”
ASH recommended that Congress make passing full and final spending legislation for FY2017 – which includes $ 34.1 billion for NIH – a priority when it reconvenes in November . The Society is committed to working with lawmakers to pass a full FY2017 that ensures that lifesaving biomedical research continues , while promoting public health and safety . ASH also encouraged Congress to recognize “ the amazing progress we can make towards curing cancer by funding the Precision Medicine and National Cancer Moonshot initiatives . … Without congressional
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backing , ASH and our collaborative partners in the federal government and academia cannot continue our fight to conquer cancer .”
Source : ASH news release , September 29 , 2016 .
AACR Releases 2016 Cancer Progress Report , Touts Research Outcomes The American Association for Cancer Research ( AACR ) released its “ Sixth Annual Cancer Progress Report ,” highlighting the achievements and challenges for cancer care and research .
The report lists the development of immunotherapy as “ one of the most exciting advances in cancer care ” – as checkpoint inhibitors have been approved to treat bladder cancer , head and neck cancer , Hodgkin lymphoma , kidney cancer , lung cancer , and melanoma – while also noting that collaborative efforts to accelerate advances in cancer care must remain a priority .
“ The promise of immunotherapy for cancer therapy has never been greater , and the opportunity to make significant progress in this critical area is real ,” said Nancy E . Davidson , MD , president of AACR and director of the University of Pittsburgh Cancer Institute , in a press release discussing the report . “ However , continued progress is going to require a sustained federal commitment to the research agenda .”
Some of the achievements detailed in the report included :
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• The U . S . cancer death rate has decreased by 1.5 percent per year since 2003 , largely due to better disease detection and the development of effective treatments .
• From 1991 to 2012 , the U . S . cancer death rate declined by 23 percent , translating into 1.7 million cancer deaths avoided .
• The number of cancer survivors in the United States has increased from 3 million in 1971 to 15.5 million in 2016 . Approximately 112,370 of these survivors are children or adolescents .
• Between August 2015 and July 2016 , the U . S . Food and Drug Administration ’ s ( FDA ) Center for Drug Evaluation and Research approved 40 new drugs to treat cancer as well as 11 new indications for previously approved anticancer therapeutics .
However , the report noted that not all population subgroups , including ethnic minorities , people with low socioeconomic status , older patients , and individuals who live in certain geographic regions , benefit equally from these advances . The economic toll of a cancer diagnosis was also emphasized , as direct medical costs of cancer care in the United States in 2010 were nearly $ 125 billion , with a projected increase to $ 156 billion by 2020 .
Visit cancerprogressreport . org / Pages / default . aspx to view the full report .
Source : American Association for Cancer Research news release , September 20 , 2016 .
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