Drugs

Rybrevant/Lazcluze Cancer Study Positive: J&J

Johnson & Johnson is announcing positive topline results from the Phase 3 MARIPOSA study showing that its Rybrevant (amivantamab-vmjw) plus Lazcluze (lazertinib) had a statistically significant and clinically meaningful improvement in overall survival versus standard-of-care osimertinib (AstraZeneca’s Taggrisso) as a first-line therapy for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions (ex19del) or L858R substitution mutations. It also says the chemotherapy-free combination regimen showed an improvement in median overall survival that exceeded one year.

“The combination of these two agents previously demonstrated an improvement in progression-free survival, but this does not always capture the impact on the entire treatment course,” a company release says. “Evaluation of overall survival can better demonstrate the benefit of a first-line treatment regimen.”

Regarding its safety profile, the combination regimen was generally consistent with the profiles of the individual treatments, according to the company. “Venous thromboembolic events were observed with the combination,” it says. “Subsequent studies showed that administering oral anticoagulant medicines prophylactically during the initial four months of the Rybrevant and Lazcluze regimen significantly reduced the risk of thrombosis.”

Last year, FDA granted full approval to previously accelerated-approval Rybrevant in combination with chemotherapy (carboplatin-pemetrexed) for the first-line treatment of patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations as detected by an FDA-approved test. The drug is also approved for use in NSCLC with other mutations.

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