Drugs

AstraZeneca Tagrisso Data on Improved Overall Survival

AstraZeneca says data from its ADAURA Phase 3 trial showed that its lung cancer drug Tagrisso (osimertinib) demonstrated a statistically significant and clinically meaningful improvement in overall survival compared to placebo in the adjuvant treatment of patients with early-stage epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) after complete tumor resection with curative intent. It says the new data reinforce those from 5/2020 that demonstrated a statistically significant and clinically meaningful improvement in disease-free survival in this setting.

“The ADAURA results provide powerful evidence that osimertinib offers the best possible care for patients with early-stage EGFR-mutated non-small cell lung cancer who historically faced high rates of recurrence and previously had no targeted options after surgery,” a company release says.

AstraZeneca has several ongoing trials evaluating Tagrisso in earlier stages of lung cancer, including the neoadjuvant resectable setting (NeoADAURA), the Stage IA2-IA3 adjuvant resectable setting (ADAURA2), and the Stage III locally advanced unresectable setting (LAURA). Additionally, the drug is being studied for combination use with chemotherapy in locally advanced and metastatic EGFRm NSCLC (FLAURA2).

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