UroGen's rollercoaster sees Zusduri approved
Harsh criticism of UroGen's intravesical mitomycin formulation UGN-102 at last month's US adcom put the project's approval into serious doubt. In the event, however, not only did a resulting negative vote not derail UroGen, there wasn't even a delay owing to the fact the adcom took place: US approval for low-grade intermediate-risk non-muscle invasive bladder cancer under the trade name Zusduri came on Thursday, one day before the set PDUFA date. This marks a remarkable rollercoaster for UroGen, whose stock crashed 45% when the adcom's members voted 4-5 against approval, but which surged 52% on news of the FDA's green light. Criticism centred on the company ignoring FDA advice to run a randomised trial, and the fact that its single-cohort study's primary endpoint of three-month CR rate was very short for what is an indolent disease, but neither point seems to have troubled the agency. Still awaited are FDA verdicts on the 20-21 May adcom's other subject, Roche's Columvi, Johnson & Johnson/Genmab's Darzalex and Pfizer's Talzenna.
20-21 May Oncologic Drugs Advisory Committee
| Drug | Company | Indication sought | Adcom outcome | FDA outcome |
|---|---|---|---|---|
| Zusduri | UroGen | Low-grade intermediate-risk NMIBC | Vote 4-5 against | Approved on 12 Jun (had 13 Jun PDUFA date) |
| Darzalex | J&J/Genmab | Smouldering multiple myeloma | Vote 6-2 in favour | Awaited (likely May PDUFA date) |
| Columvi | Roche | 2nd-line DLBCL (& confirmation of 3L accelerated approval) | Vote 1-8 against | Awaited (20 Jul PDUFA date) |
| Talzenna | Pfizer | 1L prostate cancer beyond HRRm disease | Vote 0-8 against | Awaited (likely Aug PDUFA date) |
Source: ApexOnco coverage.
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