Rocky road for Rubraca but Clovis remains confident
In a filing with the US Securities and Exchange Commission, Clovis Oncology (Nasdaq: CLVS) has revealed it will voluntarily withdraw part of the label for its PARP blocker Rubraca (rucaparib).
The decision relates to a previously-granted approval in BRCA-mutated ovarian cancer, as a later treatment option, after at least two lines of chemotherapy.
The Colorado, USA-based firm has been in discussion with the US Food and Drug Administration around the ARIEL4 post-marketing trial, a requirement of its Accelerated Approval in this indication.
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