Drugs

Tagrisso Phase 3 Data in Lung Cancer

AstraZeneca says data from its FLAURA2 Phase 3 trial showed that Tagrisso (osimertinib) plus chemotherapy extended median progression-free survival by nearly nine months compared to Tagrisso alone for patients with locally advanced (Stage 3B-3C) or metastatic (Stage 4) epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC). Results showed Tagrisso plus chemotherapy reduced the risk of disease progression or death by 38% compared to Tagrisso alone, it says.

The drug was approved in 2015 for patients whose tumors with EGFR mutation (T790M) and whose disease has progressed after treatment with other EGFR-blocking therapies. In 2018, expanded approval was granted for the first-line treatment of growth factor receptor EGFR mutations exon 19 deletions or exon 21 L858R.

AstraZeneca notes that it has several ongoing Tagrisso Phase 3 trials focused on earlier stages of lung cancer, including a trial in the Stage 1A2-1A3 adjuvant resectable setting (ADAURA2), and in the Stage 3 locally advanced unresectable setting (LAURA). It is also studying ways to address tumor mechanisms of resistance through the SAVANNAH and ORCHARD Phase 2 trials, and the SAFFRON Phase 3 trial.

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