Paul Schloesser
Associate Editor

Clovis Oncology is facing yet another setback with the FDA giving the battled company a complete response letter and rejecting a potential label expansion for its PARP inhibitor Rubraca.

A new SEC filing Friday detailed how it received the CRL from the FDA on May 26, rejecting an sNDA for Rubraca as a first-line maintenance treatment for women with advanced ovarian cancer who are in complete or partial response to a first-line, platinum-based chemotherapy.

FDA said that for the agency to reconsider the application, per the filing, Clovis would need to show results from an overall survival analysis that “do not demonstrate a potential OS detriment.”

In the meantime, Clovis said that the FDA’s determination would impact the timing and achievability of milestone payments that Clovis is owed. The company sold rights to its PARP inhibitor to Swiss company pharma& Schweiz GmbH in an April deal for $70 million upfront, plus another $65 million in regulatory and sales milestones.

Facing Chapter 11, Clovis sells Rubraca rights to Swiss pharma for $70M
The biotech had filed an sNDA in the US back in September, basing the request off Phase III data. Those data touted a higher rate of progression-free survival compared to placebo.

Clovis, which was founded back in 2009, got Rubraca approved initially in 2016 in ovarian cancer as a PARP inhibitor, now trailing behind PARP inhibitors brought to the market by other companies, such as AstraZeneca’s Lynparza and GSK’s Zejula. After a 2016 approval was pulled last summer upon reviewing overall survival data, the company ended up laying off 115 staffers a few months later in November 2022, and filed for bankruptcy the following month.

The same time Chapter 11 bankruptcy was announced, Clovis said it would plan on auctioning off FAP-2286, a fibroblast activation protein (FAP) targeting candidate, to Novartis for $50 million upfront. An additional $600+ million in milestones is on the line if the candidate does well.

The penny stock biotech is now trading at under 3 cents a share.

Reference: https://endpts.com/