In free fall, Clovis defaults on loan and agrees to further restrict Rubraca use

With bankruptcy looming for Clovis Oncology, the company has defaulted on a loan by failing to make an interest payment that was due Nov. 1—with a 30-day grace period to Dec. 1, according to a securities filing (PDF).

Colorado-based Clovis also revealed in the Form 8-K filing that it decided—at the request of the FDA—to restrict the use of its cancer drug Rubraca to those whose tumors have BRCA mutations.

Both the default and the label restriction are further indications the company is on the verge of going under. “Given the company’s previously disclosed liquidity situation, the company currently expects to file a voluntary petition under Chapter 11 of the U.S. Bankruptcy Code in the very near term,” Clovis wrote.

In the event of default, according to the filing, the trustee, The Bank of New York Mellon Trust Company, may cause the principal and interest to become “immediately due and payable.”

The label restriction for Rubraca comes after the FDA threatened to convene an advisory committee on the issue. Clovis made that admission in a Nov. 14 filing with the Securities and Exchange Commission.

Rubraca was previously sanctioned as a second-line maintenance treatment for those with recurrent ovarian cancer who’ve responded to chemotherapy regardless of their BRCA biomarker status.

The move is another setback for Rubraca. In June of this year, Clovis withdrew a late-line ovarian cancer indication because a study, which showed the drug could stall disease progression, also indicated an increased risk of death over chemotherapy alone.

Limiting Rubraca’s use comes amid FDA scrutiny of drugs in the PARP class. Last month, GSK made a move to limit the use of its ovarian cancer therapy Zejula. Also in the PARP class is AstraZeneca and Merck’s Lynparza.