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# Another Sponsor Quits Over Post-marketing Study Disagreement
- URL: https://www.fdaweb.com/another-sponsor-quits-over-post-marketing-study-disagreement/
- Published: 2022-01-28T12:00:00.000Z
- Updated: 2026-09-14T17:30:24.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5151035

For the second time in three days, an accelerated approval application has been withdrawn due to disagreements with FDA over confirmatory/post marketing study commitments. On 1/28, Regeneron Pharmaceuticals and Sanofi withdrew their supplemental BLA for Libtayo (cemiplimab-rwlc) as a second-line treatment for patients with advanced cervical cancer because they were unable to “align on certain post-marketing studies” with the agency. Earlier this week, Incyte said that after discussions with FDA, it has made a business decision to withdraw its NDA for parsaclisib to treat patients with three forms of lymphoma because the confirmatory studies FDA sought could not be completed within a period that would support the investment ([see story](https://www.fdaweb.com/incyte-pulling-parsaclisib-nda/)).

Recently, FDA commissioner nominee **Robert Califf** said he’s a “fan” of the accelerated approval process but wants to see changes to speed confirmatory trials to determine if therapies that are given accelerated approval deliver the benefit they claim ([see story](https://www.fdaweb.com/improve-accelerated-approval-process-califf/)). Speaking as a member of a [panel](https://www.youtube.com/watch?list=PL1Ksvj0Lu41MuKfbt%5FqIerSAQtWBtpthi&v=T6q-Z0MytEg&ref=fdaweb.com) on accelerated approval at the 1/9 UCSF-Stanford Center of Excellence in Regulatory Science and Innovation “Innovations in Regulatory Science” summit, Califf said accelerated approval was a topic of discussion in his meetings with many senators as part of the confirmation process.

During his confirmation hearing last month ([see story](https://www.fdaweb.com/califf-vows-war-on-social-media-rx-promos/)), Califf was asked by Senator **Richard Burr** (R-NC) for assurances that FDA’s accelerated approval program will not be watered down due to [recent criticisms](https://www.fdaweb.com/house-chairs-want-aduhelm-info-from-fda/) in the wake of Biogen’s approved Alzheimer’s drug Aduhelm (aducanumab). He again offered his support of the program, adding: “Accelerated pathway means that we’re accepting that there's more uncertainty, and the FDA has tremendous latitude about the decision it makes with those pathways. That means we got to have a better system to evaluate these products as they're used on the market, and I think there are ways that we can do that now. Technology is making this possible in a way that just wasn't possible before.”

***FDA Webview*** asked the agency to comment on whether stricter post marketing commitments are now being sought from companies seeking accelerated approval, but at press time no response had been received.