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Showing posts with the label FDA ODAC

Anita's Excellent Adventure: I Speak Before the FDA ODAC

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During a clinical trial clinic visit in January, my trial coordinator at Roswell Park Cancer Institute asked me if I would be interested in speaking before the FDA’s Oncologic Drug Advisory Committee about my experience as a patient taking the experimental drug rociletinib. Clovis Oncology, the company that makes and is testing the drug, was hoping to receive accelerated approval to start being able to sell this drug on the market, and a hearing scheduled for Tuesday, April 12 before this important advisory committee was key. The company was looking for patients to speak about their experience with the drug.  I immediately said yes. Such opportunities are rare, and it’s exciting to have an opportunity to be part of the important process of drug approval beyond taking a drug as an experimental subject. As a bonus, the hearing would be held in Silver Spring, MD, near where our daughter lives, and I would get to see her and her husband. In February, I talked with an executive...

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To help improve outcomes for people like me with EGFR mutated lung cancer, please donate to the EGFR Resisters' Research Fund. All donations are tax deductible and are in a restricted fund with the Bonnie Addario Lung Cancer Foundation, a four-star rated charity. Thank you from the bottom of my heart!