First family wraps up Maine holiday
BAR HARBOR, Maine | President Obama and the first family are headed home to Washington after their weekend vacation on the coast of Maine.
The president, first lady Michelle Obama and daughters Malia and Sasha boarded a small military jet serving as Air Force One and took off from the Bar Harbor airport on Sunday morning.
Their visit to Maine began on Friday. The Obamas spent much of their time hiking and biking in Acadia National Park. They also played tennis, went boating and enjoyed the food in the coastal resort town of Bar Harbor.
Scientists say drug didn’t extend lives
Federal health scientists said that follow-up studies of a Roche breast cancer drug showed that it failed extend patient lives, opening the door for it to be potentially withdrawal for use in treating that disease.
The Food and Drug Administration approved Roche’s blockbuster Avastin in 2008 based on a trial showing it slowed growth of tumors caused by breast cancer. The decision was controversial because drugs for cancer patients who have never been treated before must usually show evidence they extend lives.
Avastin’s so-called “accelerated approval” was based on the condition that later studies would show a survival benefit.
But in briefing documents posted online, FDA reviewers said two follow-up studies recently submitted by Roche failed to show that Avastin significantly extended lives compared with chemotherapy alone.
Additionally, the FDA said that in follow-up studies the drug did not slow tumor growth to the same degree as in earlier studies.
Patients taking Avastin showed significantly more side effects, including high blood pressure, fatigue and abnormal white blood-cell levels.
On Tuesday, the FDA will ask a panel of outside cancer experts to review the evidence on Avastin. The panel’s recommendations are not binding, but the FDA usually follows their guidance.