The U.S. Food and Drug Administration (FDA) approved the use of Gleevec (imatinib; Novartis) in combination with chemotherapy to treat children newly diagnosed with Philadelphia chromosome–positive (Ph+) acute lymphoblastic leukemia. The tyrosine kinase inhibitor was approved in 2011 to treat children newly diagnosed with Ph+ chronic myeloid leukemia.
A phase III clinical trial has shown that Abraxane (nab-paclitaxel; Celgene) plus gemcitabine can extend survival of late-stage, treatment-naïve pancreatic cancer patients. The MPACT (Metastatic Pancreatic Adenocarcinoma Clinical Trial) investigation among 861 patients revealed that patients treated with the drug combination had a median overall survival of 8.5 months, versus 6.7 months for patients receiving gemcitabine alone. Results were presented in January at the American Society of Clinical Oncology 2013 Gastrointestinal Cancers meeting.
Stemline Therapeutics of New York, NY, raised about $38 million in the first U.S. biotech initial public offering of 2013. The company develops therapeutics that target cancer stem cells and tumor bulk.
The time required for regulatory approval for starting clinical research varied widely across geographic regions in the Adjuvant Lapatinib and/or Trastuzumab Treatment Optimization (ALTTO) international phase III study (Oncologist 2013 Jan 28 [epub ahead of print]). The median time to regulatory approval was 236 days in South America, 62 days in the Asia-Pacific, 52 days in Europe, and 26 days in North America, the study reported.
The European Medicines Agency finalized its updated guidelines for evaluating cancer therapies.
In the fourth quarter of 2012, $1.3 billion was invested in 135 U.S. biotechnology firms, according to the MoneyTree Report by PricewaterhouseCoopers and the National Venture Capital Association (NVCA) based on data from Thomson Reuters. “Life sciences investment was suppressed for much of the year, particularly with first-time fundings, due in part to the impact of the regulatory and reimbursement environments,” comments NVCA president Mark Heesen.
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