Drugs

FDA Approves Ipsen’s Pancreatic Cancer Drug

FDA has approved an Ipsen Biopharmaceuticals NDA for Onivyde (irinotecan liposome) for use in combination with oxaliplatin, fluorouracil, and leucovorin for first-line treatment of metastatic pancreatic adenocarcinoma.

Approval was based on data from the company’s NAPOLI 3 trial (NCT04083235), a large-scale study involving 770 patients who had not previously undergone chemotherapy for metastatic pancreatic adenocarcinoma, according to an agency release. The trial compared the efficacy of the newly approved regimen, referred to as NALIRIFOX, with the standard gemcitabine plus Nab-paclitaxel (Gem+NabP) treatment.

Data from from NAPOLI 3 showed evidence of the superiority of NALIRIFOX over the Gem+NabP arm. The agency says that the primary efficacy measure, overall survival (OS), showed a statistically significant improvement with a median OS of 11.1 months for patients on NALIRIFOX compared to 9.2 months for those on Gem+NabP. Similarly, progression-free survival (PFS) was markedly extended in the NALIRIFOX group, with a median PFS of 7.4 months compared to 5.6 months in the Gem+NabP group, it says.

On the safety side, FDA says the most common adverse reactions observed (greater than or equal to 20% and a significant difference between arms) included diarrhea, fatigue, nausea, vomiting, decreased appetite, abdominal pain, mucosal inflammation, constipation, and decreased weight. Furthermore, notable laboratory abnormalities (Grade 3 or 4) associated with NALIRIFOX included decreased neutrophils, potassium, lymphocyte counts, and hemoglobin levels.

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