US FDA Accepts Supplemental Biologics License Application for Imfinzi in Locally Advanced Unresectable Non-Small Cell Lung Cancer

Excerpt:

“AstraZeneca and MedImmune, its global biologics research and development arm, today announced that the US Food and Drug Administration (FDA) has accepted a supplemental Biologics License Application (sBLA) for Imfinzi (durvalumab) for the treatment of patients with locally advanced (Stage III) unresectable non-small cell lung cancer (NSCLC) whose disease has not progressed following platinum-based chemoradiation therapy. The FDA has granted Imfinzi Priority Review status.”

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AstraZeneca Immunotherapy Study Shows Benefit for Niche Group of Lung Cancer Patients

Excerpt:

The jackpot cancer immunotherapy ambitions of AstraZeneca stumbled in July with the failure of a closely watched clinical trial in newly diagnosed lung cancer. Friday, the Anglo-Swedish drugmaker attempts a recovery with positive results from a new study, also in lung cancer, but aimed at a niche group of patients.

“AstraZeneca still trails cancer immunotherapy leaders Merck and Bristol-Myers Squibb, but staking a claim in lung cancer marks progress.”

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AstraZeneca Plunges After Setback in Crucial Lung-Cancer Drug Trial

Excerpt:

AstraZeneca Plc plunged by a record after suffering a setback to its next-generation cancer medicine, hurting Chief Executive Officer Pascal Soriot’s ambition to join the league of the world’s five largest drugmakers.

“A combination of two immuno-therapies — part of a new class of drugs that activate the body’s defense system to attack tumors — failed to do better than chemotherapy in checking the growth of lung tumors in some patients in the study dubbed Mystic, the U.K. drugmaker said in a statement on Thursday. The drugs were poised to generate more than $7 billion in sales by 2022, according to analysts’ estimates compiled by Bloomberg, and would have made the Imfinzi treatment into Astra’s best-selling medicine.”

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