publication date: Jun. 27, 2014
20140627 - Jun. 27, 2014
ISSUE 26 – JUNE 27, 2014PDF



ODAC Clarifies Standards for Maintenance In Ovarian Cancer;
Nixes Olaparib in 11-2 Vote

Some of the questions that landed the AstraZeneca drug Olaparib (lynparza) before the FDA Oncologic Drugs Advisory Committee were classic:

• How much progression-free survival is enough?

• Can you make use of post-hoc analysis to identify a cohort in which the drug appears to be most effective?

Two big questions in their own right, but in the case of Olaparib, these questions were even more important because of the setting. Olaparib is intended as maintenance for relapsed ovarian cancer, where the standard of care is no cancer drugs at all.

Joint NCAB-BSA Meeting
NCI Prepares for Intramural Program Review

NCI has received some relief from sequestration, and the budget cuts will be adjusted proportionally, Director Harold Varmus said at the joint meeting of the National Cancer Advisory Board and the Board of Scientific Advisors June 23.

“The FY 14 budget is not very dissimilar from last year’s budget,” Varmus said. “We had relief from sequestration. We have correspondingly reduced the level of cuts we have imposed on both competitive and non-competitive awards. We expect to be awarding roughly the same number of RPGs, research project grants, as we did in FY 13.”

photoGroups Urge FDA to Take More Action Against Tobacco Products

On the fifth anniversary of the landmark 2009 law granting the FDA authority over tobacco products, 10 leading public health and medical organizations called on the FDA and the Obama Administration to prioritize three actions to reduce tobacco use.

photoIn Brief

  • James Downing named CEO of St. Jude Children’s Research Hospital

  • Lynda Chin receives fellowship at MD Anderson Cancer Center

  • Thomas Hansen, CEO of Seattle Children’s, to retire in 2015

  • Cornelia Ulrich and Bruce Edgar to join Huntsman Cancer Institute

photoFDA News

  • Lymphoseek label updated to include head and neck SCC

  • Aloxi injection approved to prevent chemotherapy-related nausea and vomiting in children as young as one month old

  • Fast Track status granted to DNX-2401 in glioblastoma

  • Orphan Drug status granted to mocetinostat for myelodysplastic syndrome

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