FDA rejects Clovis' long-shot bid for approval of Rubraca

 Six months after filing for bankruptcy, Clovis Oncology was hoping for a last gasp win for fading cancer drug Rubraca. But the FDA has rejected the company’s bid for approval of the PARP inhibitor as a first-line maintenance treatment for ovarian cancer patients who have responded to a round of chemotherapy.

The Colorado-based biopharma was hit with a complete response letter from the U.S. regulator May 26, according (PDF) to a Securities and Exchange Commission (SEC) filing. The FDA said it needed to see survival data from a phase 3 study before considering the application.

Last year, the regulator warned Clovis that applying for the approval without presenting the survival data would hinder its chance for success. The company added (PDF) in an SEC filing that those results would not be available until 2024.

The problem for Clovis is that the company itself may no longer exist by then. Clovis was clinging to hope for an approval, which would have triggered a milestone fee from Pharma& Schweiz GmbH, Clovis said in its most recent filing. Two months ago, the Swiss company purchased Rubraca for $70 million, with an additional $50 million available in potential regulatory milestone payments.

With Rubraca as its lone commercial asset, 14-year-old Clovis had little chance to survive, triggering the Chapter 11 claim and the sale. The drug was originally approved in 2016 but, last June, because of death risk fears, the company withdrew its nod as a third-line treatment.

Sales of Rubraca peaked in 2020 at $164 million. Then the pandemic reduced the number of women being diagnosed with ovarian cancer, the company said, which it said impacted sales. AstraZeneca and Merck's Lynparza is the most successful PARP inhibitor, bringing in sales of $2.6 billion in 2022. 

Last year, as part of its bankruptcy procedure, Clovis also revealed that it sold cancer candidate FAP-2286 to Novartis for $50 million, with an additional $334 million due if milestones are hit and $297 million if certain sales goals are reached.

In its bankruptcy filing, Clovis revealed assets of $319 million compared to $754 million in debt. The company secured a $75 million loan to fund its operations during the procedure.

https://www.fiercepharma.com/pharma/fda-rejects-clovis-long-shot-bid-approval-rubraca