Drugs

AstraZeneca Positive Results for Imfinzi in Lung Cancer

AstraZeneca has announced positive progression-free survival (PFS) results from the Phase 3 POSEIDON trial in previously-untreated Stage IV (metastatic) non-small cell lung cancer (NSCLC) for Imfinzi (durvalumab) and tremelimumab, an anti-CTLA4 antibody, when added to chemotherapy. “The trial met a primary endpoint by showing a statistically significant and clinically meaningful improvement in the final PFS analysis in patients treated with the combination of Imfinzi and a broad choice of five standard-of-care platinum-based chemotherapy options vs. chemotherapy alone,” the company says. The triple combination also showed a statistically significant and clinically meaningful PFS improvement vs. chemotherapy alone as a key secondary endpoint.

AstraZeneca says that the POSEIDON trial will continue to assess the primary endpoint of overall survival with data expected next year. AstraZeneca says it will submit the results for presentation at an upcoming medical meeting and plans to make regulator submissions seeking related approvals. Imfinzi is also being studied tested in Stage IV NSCLC as monotherapy in the Phase III PEARL trial, and in earlier stages of disease as part of the company’s Immuno-Oncology lung cancer program.

Imfinzi is approved in the curative-intent setting of unresectable, Stage III NSCLC after chemoradiation therapy in 53 countries, including the U.S.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome