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At ESMO, data showed overall response benefit in combination with carboplatin in first-line therapy, and with Keytruda in second- or third-line treatment. The antibody-drug conjugate obtained US approval on 20 September as monotherapy.
The availability later this month of Hetero's biosimilar tocilizumab, ostensibly a less pricey product, could place India in a relatively better situation to cope with any demand spurt should another wave of COVID-19 strike. Innovator product Actemra is expected to be in short supply, going by current trends, given the unprecedented worldwide demand.
Coronavirus Notebook: New Deal To Boost Local Vaccine Manufacturing, EU Warns Of RoActemra Shortages
MSF tells G20 leaders to “put your money where your mouth is” on vaccine sharing, the UK is considering whether to vaccinate all 12-15-year olds, and the UK & Australia are to swap excess vaccines.
US FDA showed some regulatory flexibility by relying on longer-term follow-up from Merck’s original single-arm trial, rather than additional confirmatory studies, to retain the first-line claim, but it narrowed the target population to those with the greatest unmet need; Keytruda indication was one of six 'dangling' accelerated approvals re-examined by Oncologic Drugs Advisory Committee in April.
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