lunes, 13 de abril de 2020

A ray of sunlight from AstraZeneca

The Readout
Damian Garde & Meghana Keshavan

A ray of sunlight from AstraZeneca

It’s been a good few days for AstraZeneca. Selumetinib, the company’s neurofibromatosis drug, developed in conjunction with Merck, was given a speedy green light from the FDA. It’s a sign that regulators are still able to push drugs through to approval, in spite of the pandemic. 
“…in this critical time we want patients to know that the FDA remains committed to making patients with rare tumors and life-threatening diseases, and their unique needs, a top priority,” FDA cancer chief Richard Pazdur said in a statement.
Meantime, AstraZeneca abruptly ended its study of the blockbuster drug Tagrisso, citing its “overwhelming” benefit in treating lung cancer. The global trial had enrolled nearly 700 patients, and was expected to run for three years — but was halted 12 months in when an independent monitoring committee found that Tagrisso had already outmatched placebo, STAT’s Damian Garde writes.
“Frankly to have a study that reports two years ahead of time, where the [data monitors] call you and say, ‘Guys you need to stop the study,’ this is totally remarkable to me,” AstraZeneca’s head of oncology research told STAT. “I can’t recall such a premature readout of a study of this type.”

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