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H. Jack West, MD
Medical Director, Thoracic Oncology Program, Swedish Cancer Institute, Seattle, WA; CEO, Global Resource for Advancing Cancer Education (GRACE)

Clovis Oncology Initiates Rolling NDA Submission to the FDA for Rociletinib in the Treatment of Advanced EGFR-Mutant Non-small Cell Lung Cancer

(MarketWatch) July 1, 2015 - Clovis Oncology, Inc. announced today that it has commenced the submission of a New Drug Application (NDA) regulatory filing to the U.S. Food and Drug Administration (FDA) for rociletinib for the treatment of patients with mutant epidermal growth factor receptor (EGFR) non-small cell lung cancer (NSCLC) who have been previously treated with an EGFR-targeted therapy and have the EGFR T790M mutation as detected by an FDA approved test.

Commentary: Both this agent and AZD9291 (merelitinib, but I understand that name may be changing) have impressive activity...



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Clovis Oncology Initiates Rolling NDA Submission to the FDA for Rociletinib in the Treatment of Advanced EGFR-Mutant Non-small Cell Lung Cancer

(MarketWatch) July 1, 2015 - Clovis Oncology, Inc. announced today that it has commenced the submission of a New Drug Application (NDA) regulatory filing to the U.S. Food and Drug Administration (FDA) for rociletinib for the treatment of patients with mutant epidermal growth factor receptor (EGFR) non-small cell lung cancer (NSCLC) who have been previously treated with an EGFR-targeted therapy and have the EGFR T790M mutation as detected by an FDA approved test.
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Celgene’s $138,000 Doctor Payment Left Off Study Disclosures

(Bloomberg) July 1, 2015 - A cancer doctor failed to disclose in a scientific journal that he had received more than $138,000 in cash and goods from Celgene Corp., even though he was assessing the company’s drug Revlimid.
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News Story Commentary By Academic and Community Oncologists



Clovis Oncology Initiates Rolling NDA Submission to the FDA for Rociletinib in the Treatment of Advanced EGFR-Mutant Non-small Cell Lung Cancer (MarketWatch)

Both this agent and AZD9291 (merelitinib, but I understand that name may be changing) have impressive activity...posted by: H. Jack West, MD

Why Gene-Editing Technology Has Scientists Excited (Wall Street Journal)

CRISPR is a phrase that we all need to watch carefully as it probably represents the most promising biologic technique...posted by: Dean Gesme, MD

NCCN Receives $2 Million in Research Funding from Boehringer Ingelheim to Study Targeted Combination Approaches with Afatinib in Lung Cancer (NCCN)

NCCN is an alliance of 26 academic cancer centers with missions in research, teaching and patient care. Since...posted by: Robert Carlson

How Much Should Cancer Drugs Cost? (Wall Street Journal)

The DrugAbacus is an excellent starting point in an attempt to evaluate the true cost benefit of oncology drug....posted by: Winston, Wong, PharmD

Cancer Doctors Offer Way to Compare Medicines, Including by Cost (New York Times)

Hats off to ASCO for venturing into an area that is critical to the future of our individual patient's financial...posted by: Dean, Gesme, MD






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