Biologics

Panel Input on Need for New Imfinzi Trial: FDA

FDA is planning to ask an advisory committee 7/25 whether a new trial should be conducted before approving an AstraZeneca supplemental BLA for Imfinzi (durvalumab) injection that is seeking its use in combination with platinum-containing chemotherapy as neoadjuvant treatment. The application proposes that this would then be followed by Imfinzi as monotherapy after surgery in adult patients with resectable non-small cell lung cancer and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase rearrangements. A just-released briefing document notes that due to the “uncertainty around the need for both phases of treatment,” panel members will be asked to discuss whether an additional trial should be conducted to clarify the contribution of the treatment phase for the durvalumab perioperative regimen.

In the briefing document, FDA acknowledges that AstraZeneca’s AEGEAN trial met its primary endpoint and demonstrated a statistically significant and clinically meaningful improvement in event-free survival (EFS). “While FDA concurs that AEGEAN demonstrated an EFS benefit of perioperative durvalumab that extends into the post-surgery period, FDA clarifies that the AEGEAN trial design does not allow the ability to determine if the benefit observed in the post-surgery period requires the addition of the adjuvant durvalumab phase,” it says. “Since the experimental arm of AEGEAN included durvalumab in both the neoadjuvant and adjuvant phases, the post-surgery EFS benefit could reflect the effect of neoadjuvant chemotherapy in combination with durvalumab.”

FDA also clarifies in the document that the overall survival (OS) analysis conducted at the 120-day safety update “suggests there is no detrimental effect of the experimental regimen on OS rather than supporting the claim that there is a trend for improved OS favoring the durvalumab arm, which AstraZeneca has stated.

“While AEGEAN provides evidence of benefit as measured by EFS for patients receiving perioperative durvalumab, to date there is no evidence of an overall survival benefit, and the improvement in EFS cannot be interpreted as a predictor for an improvement in long-term survival,” it says.

FDA says the advisory committee focus should not be on the EFS results, but rather it should discuss the “high uncertainty around the contribution of phases (particularly the need for the adjuvant treatment in addition to neoadjuvant chemoimmunotherapy) precludes our ability to adequately assess the EFS benefit in light of potential overtreatment.”

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