Biologics

Rybrevant Beats Tagrisso in Head-to-Head Trial: J&J

Johnson & Johnson says data from its Phase 3 MARIPOSA study, a head-to-head study comparing the company’s Rybrevant (amivantamab-vmjw) versus AstraZeneca’s Tagrisso (osimertinib), showed that Rybrevant plus Janssen’s Lazcluze (lazertinib) outperformed Tagrisso by a three-to-one margin, significantly extending overall survival (OS) in the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor exon 19 deletions or L858R substitution mutations. “Median OS is projected to exceed one year beyond the median of three years observed with osimertinib…,” J&J says.

The company says the Rybrevant combination also prolonged multiple secondary endpoints vs osimertinib, including intracranial progression-free survival, intracranial duration of response, and intracranial overall response rate. “Notably, Rybrevant plus Lazcluze prolonged time to symptomatic progression (TTSP) – the time from treatment randomization to the onset of lung cancer symptoms – by more than 14 months compared to osimertinib (43.6 months vs 29.3 months),” it says.

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