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 approvals

Note: updated to correct the LItespark-005 setting. Source: OncologyPipeline.