Drugs

Panel Votes Down Amgen’s Confirmatory Study

FDA’s Oncologic Drugs Advisory Committee 10/5 voted 10 to 2 that the CodeBreak 200 confirmatory study, with its progression-free survival primary endpoint, cannot be reliably interpreted as the basis for Amgen’s request to have Lumakras’s (sotorasib) 5/28/21 accelerated approval converted to a full approval. Lumakras is an oral targeted therapy to treat patients with KRAS G12C-mutated non-small cell lung cancer.

Panel members echoed concerns raised in an FDA briefing document released before the panel met. In it, medical reviewers noted that the median progression-free survival benefit of about five weeks was less than the standard imaging interval of six weeks. The reviewers also looked at multiple sources of potential systemic bias in the trial: (1) asymmetric early dropout, with greater dropout on the docetaxel control arm; (2) investigator assessments of progressive disease favoring the sotorasib arm; and (3) crossover of patients from docetaxel to sotorasib before assessment of disease progression by BICR (blinded independent central review).

The reviewers concluded that the trial results are confounded by multiple sources of systemic bias, raising concerns about whether CodeBreak 200 can be considered an adequate and well-controlled 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

Read more

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