Jemperli arrives just as accelerated approvals face a grilling

With yesterday’s green light for Glaxosmithkline’s dostarlimab, some five months late owing to Covid-19 travel restrictions, the industry has its seventh US-approved anti-PD-(L)1 drug. The initial use, second-line mismatch repair-deficient endometrial cancer, is a small niche, and Merck & Co’s Keytruda can already be given for second-line MSI-high/mismatch repair-deficient cancers – irrespective of tumour type. Immediate winners are Roche, whose Ventana MMR RxDx companion diagnostic is concurrently approved, and Anaptysbio, which scored a $20m milestone payment; Glaxo investors might now wonder how long it will be before dostarlimab, now branded Jemperli, generates the cash flow to cover the milestone. Evaluate Pharma sellside consensus sees Jemperli revenues rising from an anaemic $37m this year to $546m in 2026. The conditional approval came five days before a US adcom seeking to scrutinise the ongoing accelerated approvals of anti-PD-(L)1 drugs whose confirmatory studies have failed. As a just-published report from Evaluate Vantage reveals, this conditional pathway has found particular favour with anti-PD-(L)1 drugs, with Keytruda alone having 18 accelerated approvals to its name, 11 of which remain unconfirmed. Jemperli plus chemo is in Ruby, a controlled phase 3 endometrial cancer study that might be used to confirm yesterday’s approval.