ESMO: Padcev/Keytruda Combo Edges Closer To First-Line Bladder Cancer Filing
Big Boost For Seagen
Full data presented at ESMO from a closely watched trial of Seagen/Astellas’s Padcev and Merck & Co’s Keytruda should support regulatory approval of the combination in cisplatin-ineligible first-line metastatic urothelial cancer patients but concerns over duration of treatment remain.
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After more than three months of speculation about a possible Merck & Co buyout, the chatter has gone quiet – but the deal might not be dead yet.
The Seattle-based biotech reported a 24% increase in product sales in the second quarter amid speculation that Merck is about to acquire the company.
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.