Clovis Withdraws Rubraca Ovarian Cancer Indication Due To Survival Imbalance

Third-line BRCA-mutated ovarian cancer indication is not a major loss for Rubraca, but Clovis also faces delay in filing to add first-line ovarian cancer therapy to product label.

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Clovis's timeline for adding to Rubraca's ovarian cancer labeling is uncertain

Clovis Oncology, Inc. is facing a double-hit for its stumbling PARP inhibitor Rubraca (rucaparib), as it has voluntarily withdrawn an indication for third-line ovarian cancer in the US due to safety concerns and is facing a significant delay in the filing timeline for a significant supplemental indication, first-line maintenance therapy in ovarian cancer. The company also appears concerned about ripple effects for the drug’s larger indications.

The third-line ovarian cancer indication is not a large one for the company, but Clovis indicated in an 8-K filed with the US Securities and Exchange Commission on 16 June that “this withdrawal may have an impact on the company’s sales outlook outside the treatment indication

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