(CercleFinance.com) – Novartis announces that the US FDA has granted accelerated approval for Kymriah for the treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.
This approval is based on the phase II ELARA trial, in which ‘68% of patients receiving Kymriah had a complete response, with an overall response rate of 86%, as well as an outstanding safety profile’.
‘The maintenance of the approval of this indication may be subject to the verification and description of the clinical benefit in the confirmatory trials’, nevertheless specifies the Swiss pharmaceutical group.
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