No overall survival not a problem for Welireg

Yesterday’s US approval for Merck & Co’s Welireg offers another lesson in how apparently easy some companies are finding it to negotiate a fast regulatory pathway with the FDA. Not only did the approval, in second/third-line renal cancer, come just three months after filing acceptance – and a month before the PDUFA date – it was granted despite the lack of an overall survival benefit. The supporting trial, Litespark-005, had read out positively for PFS versus everolimus, but on OS there was no benefit, and moreover there appeared to be little chance of showing one in future. Full data at ESMO revealed that the hazard ratio had numerically slightly worsened between the first and second interim analyses, and the study’s discussant expressed disappointment about this and about the possible inadequacy of everolimus control. That said, Litespark-005 might have been hampered by crossover and patient censoring, and it must be remembered that it represents a relatively late-stage post-PD-(L)1 setting. Other speedy recent oncology approvals with the FDA include Keutryda, Fruzaqla and Augtyro. Selected recent US oncology drug approvalsDrugCompanyIndicationPDUFA dateApproval dateKeytrudaMerck & Co1st-line biliary tract cancer7 Feb 20241 Nov 2023FruzaqlaHutchmed/ Takeda3rd/4th-line colorectal cancer30 Nov 20239 Nov 2023AugtyroBristol Myers SquibbROS1 +ve NSCLC27 Nov 202315 Nov 2023KeytrudaMerck & CoHER2 -ve gastric/GEJ adenocarcinoma16 Dec 202316 Nov 2023WeliregMerck & CoPost PD-(L)1 + VEGF inhibitor (given sequentially or in combination) renal cancer17 Jan 202414 Dec 2023Note: updated to correct the LItespark-005 setting. Source: OncologyPipeline.