The new normal in US oncology approvals
Nearly two thirds of key oncology filings are expedited; and what about the ones that aren’t?
Nearly two thirds of key oncology filings are expedited; and what about the ones that aren’t?
Recent FDA approvals have confirmed, as if any confirmation were needed, that the US regulator tends to move quickly when it comes to cancer drugs – notwithstanding its backlog and often cited heavy workload.
Such speed comes on top of any extra measures designed to hurry along regulatory action; a glance at recent and upcoming US oncology decisions shows that priority review is basically the order of the day. True to form, Regeneron’s first filing for the anti-BCMA T-cell engager linvoseltamab, accepted yesterday, came with priority review and a promise to act within six months.
Analysis by ApexOnco of the upcoming 25 most important first and supplementary US filings shows some 60% of these being granted priority review.
In recent days filings granted priority review have also included Servier’s vorasidenib in IDH-mutant diffuse glioma – despite the fact that ASCO revealed two probable cases of Hy’s law in its registrational Indigo trial – and Bristol Myers Squibb’s Krazati in colorectal cancer, where the drug’s originator Mirati had first made a splash over two years ago.
And the sponsors of such projects can rest assured that a regulatory nod, if granted, will likely come even earlier than the formally stated action date (21 June for Krazati, 20 August for vorasidenib and 22 August for linvoseltamab).
Any such optimism will be driven by recent precedent for US approvals granted priority review: nods for Fruzalqa, Keytruda, Padcev, Augtyro, Truqap, Welireg and Amtagvi all came between one week and five months before their action date, though the last had suffered a three-month PDUFA date delay owing to “resource constraints”.
Even Keytruda’s other recently approved use, biliary tract cancer, was given the green light three months early despite only receiving standard review. Meanwhile, two other drugs under standard review, Onivyde and Ogsiveo, weren’t approved before their PDUFA dates.
And the rest
Naturally, when expedited review times are the order of the day, an obvious spotlight falls on oncology projects not granted such an accolade. In the case of me-too PD-(L)1 drugs like BeiGene’s tislelizumab and Jiangsu HengRui’s camrelizumab, separately delayed by Covid-related travel restrictions, their relative lack of novelty likely put them on a US slow track.
Autolus recently disappointed when revealing that its obe-cel filing was given standard 10-month review, and a 16 November PDUFA date. The company’s protestations notwithstanding, it again seems apparent that the FDA doesn’t view obe-cel as especially innovative, the therapy being yet another autologous CD19-directed Car-T.
And AstraZeneca/Daiichi Sankyo’s anti-Trop2 ADC datopotamab deruxtecan was accepted for standard review last week, in second-line NSCLC. This is clearly a novel use – the project isn’t yet approved anywhere, and no Trop2-directed drugs are available for lung cancer.
But Astra’s filing was notable for not even attempting to seek a broad label, the company revealing that it was seeking go-ahead only in the non-squamous histology, the subgroup that appeared to drive all the efficacy the Tropion-Lung01 trial. The action date is 19 December.
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