Biologics

J&J Combo Approved for Lung Cancer

FDA has approved a Johnson & Johnson BLA for Rybrevant (amivantamab-vmjw) plus Lazcluze (lazertinib) for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations. The company says the combination is the only “multitargeted, chemotherapy-free combination regimen with demonstrated superiority versus Osimertinib [AstraZeneca’s Tagrrisso] approved for the first-line treatment of patients with EGFR-mutated NSCLC.”

Rybrevant is described as an EGFR- and mesenchymal epithelial transition-directed bispecific antibody that stimulates the immune system, and Lazcluze is characterized as a highly selective, brain-penetrant, third-generation oral EGFR tyrosine kinase inhibitor.

Approval was based on data from the Phase 3 MARIPOSA study, which showed that the combination reduced the risk of disease progression or death by 30% compared to osimertinib (median progression-free survival — 23.7 months versus 16.6 months) in the targeted patient population. The median duration of response was nine months longer with Rybrevant plus Lazcluze compared to osimertinib (25.8 months versus 16.7 months, respectively).

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