US shutdown freezes new drug applications

Despite a contingency plan pledging to keep 86% of the FDA's staff on duty during the ongoing US government shutdown, several key activities are expected to be disrupted; and for drugmakers the slowdown could be painful.

According to the FDA’s plan, announced on Wednesday, the agency will not accept new drug applications, which could hit planned filings for Amgen, Regeneron, Lilly and others. It’s also possible that lower staff levels could lead to delays for projects that have already been filed and are under review, though Thursday's approval of Zepzelca will offer some hope.

The shutdown, currently in effect, could last for weeks. It stems from a deadlock in Congress over funding for the 2026 fiscal year, with Democrats and Republicans unable to agree on key budget issues, including healthcare policy.

By comparison, the previous shutdown in December 2018/January 2019, during Donald Trump’s first term as president, was the longest in US history, lasting 35 days. If this one lasts as long, the normal FDA operations might not resume until November, leaving biopharma companies in a holding pattern at a crucial point, when many had been gearing up for year-end approvals.

No new submissions

While delays to existing filings are hard to quantify, new filings are definitely on ice.

Amgen, for instance, has already filed Imdelltra in second-line small-cell lung cancer on the basis of the Dellphi-304 trial in Europe and China, but unless it managed to sneak in its US dossier before the shutdown began the NDA will now sit pending indefinitely.

Nuvalent had started a rolling submission for zidesamtinib in ROS1-positive non-small cell lung cancer, based on the Arros-1 trial. The filing was expected to be completed in the third quarter, but final submission now appears stalled, despite the fact that some work will have been done in reviewing initial documents.

The uncertainty extends to AbbVie. Just one day before the shutdown started, the company said it had filed pivekimab sunirine in blastic plasmacytoid dendritic cell neoplasm based on the Cadenza study. Acceptance of that filing, however, will surely be delayed until the shutdown lifts.

Notable filings expected by year end 2025

Source: OncologyPipeline.

As for the various projects awaiting approval decisions, some of these might be delayed. These include GSK’s Blenrep, Syndax’s Revuforj and Regeneron’s Libtayo, which are all due decisions this month.

Blenrep in particular is under the spotlight. The multiple myeloma therapy already saw its action date slip from July to October after GSK submitted additional data in an attempt to sway regulators after an adcom voted against the approval on the basis of the Dreamm-7 and 8 trials.

A potential silver lining for those companies came on Thursday, when Jazz’s Zepzelca, filed in combination with Tecentriq, won approval for first-line small-cell lung cancer maintenance.

Notable approvals decision due by YE2025

Source: Oncology Pipeline.