FDA Calls for Restrictions on Ovarian Cancer Drug Rubraca Due to High Mortality Rates

If the drug maker Clovis does not update the Rubraca label, the FDA may seek third party recommendations on whether to remove Rubraca from the market

Federal health officials are calling for the drug maker Clovis to limit the use of its ovarian cancer medication, Rubraca, following new clinical trial data that suggests side effects may increase the risk of death among patients with certain types of aggressive ovarian cancer.

Rubraca (rucaparib) is a new-generation cancer medicine introduced by Clovis Oncology in April 2018, which interferes with the growth and spread of cancer cells in the body. The drug was approved by the U.S. Food and Drug Administration (FDA) as a second-line maintenance treatment for patients with BRCA mutation-associated advanced ovarian cancer who have been treated with two or more chemotherapies.

The drug is part of a class of medications which provide targeted therapy known as a PARP inhibitor, which works by blocking an enzyme that helps repair damaged DNA and to helps to kill cancer cells and shrink tumors.

While early clinical trial data on Rubraca provided to the FDA showed tumor progression benefits when compared with a placebo, post-marketing clinical trials involving additional patient data has shown Rubraca may increase death rates among users.

Rubraca Side Effects Increased Risk of Death

The findings of a phase 3 clinical trial, ARIEL3, were presented at this year’s International Gynecologic Cancer Society, indicating that ovarian cancer patients with elevated levels of genetic abnormalities taking Rubraca faced a 28% increased risk of mortality when compared to those in the placebo group. The data further indicated patients being treated with Rubraca that did not have BRCA mutations faced a 15% increased risk of death when comparted to those in the placebo group.

After reviewing the results of the available data, the FDA scheduled a meeting with Clovis Oncology on November 14, which was held by teleconference to discuss the overall survival (OS) data from the Company’s ARIEL3 clinical trial.

Based on the negative findings, the FDA is now calling for Clovis to voluntarily revise the label to limit the indication of Rubraca in this second-line maintenance treatment to tBRCA patients only, in an effort to reduce the probability of death.

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The FDA’s recommendation was reinforced by a strong message to Clovis, indicating that if the company fails to follow the recommendation, the agency would be forced to convene an Oncologic Drugs Advisory Committee (ODAC) meeting to further review the findings and establish seek third party expert recommendations on whether the drug should remain available on the market for its currently approved use.

At this time, Clovis has yet to issue a formal response and is reportedly still evaluating the terms of the FDA’s request and whether the company will comply with the recommendation.

Clovis Oncology May Be Near Bankruptcy

Reports have suggested that Clovis Oncology, Inc. may be headed for bankruptcy in the coming months, following a September 2022 filing with the Securities Exchange Commission indicating the company may not be able to continue operations beyond a year of the filing.

The manufacturer stated that ongoing concerns about the FDA’s investigation into Rubraca’s overall survival rate, in addition to significant net losses since inception, raised doubt about Clovis’s ability to continue operations throughout 2023.

“Based on our current cash and cash equivalents, together with current estimates for revenues to be generated by sales of Rubraca, we will not have sufficient liquidity to maintain our operations beyond January 2023”, Clovis stated in its Quarterly Report.


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