Clovis Oncology, Inc. ( CLVS Quick Quote CLVS - Free Report) submitted a supplemental new drug application (sNDA) with the FDA and a Type II variation with the European Medicines Agency (EMA), seeking approval for its PARP inhibitor, Rubraca (rucaparib), for expanded use in ovarian cancer
The applications seek label expansion for Rubraca as a first-line maintenance treatment in women with advanced ovarian cancer who have responded to platinum-based chemotherapy.
The drug is already approved in the United States and Europe as a second-line maintenance treatment for recurrent ovarian cancer in patients who are in response (complete or partial) to platinum-based chemotherapy. The drug is also approved in Europe in the third or later-line setting in ovarian cancer.
Clovis’ regulatory filings are based on positive data from the monotherapy arm of the phase III ATHENA study (ATHENA-MONO), which evaluated Rubraca as monotherapy in advanced ovarian cancer as a first-line maintenance treatment. The ATHENA-MONO study achieved its primary endpoint of a statistically significant progression-free survival (PFS) versus placebo in the first-line setting. The drug’s safety was consistent with the current U.S. and Europe labels.
Shares of Clovis have declined 45.0% in the year so far compared with the
industry’s 20.9% fall. Image Source: Zacks Investment Research
In May, vide an SEC filing, Clovis announced that it had discussed the path with the FDA for the label expansion of Rubraca as a first-line ovarian cancer maintenance treatment. However, the regulatory body recommended the company not to submit the sNDA until the overall survival (OS) data is at least 50% mature. During that time, management believed that the data was only 25% mature and would take approximately two years to reach the intended maturity.
Since Clovis submitted the sNDA and went against the FDA’s recommendation for OS data maturity, the regulatory authority will consider OS data from other clinical studies evaluating Rubraca. In addition, the FDA may also hold an Oncologic Drugs Advisory Committee (ODAC) meeting to discuss the data from the ATHENA-MONO study.
In June 2022, Clovis announced its decision to withdraw Rubraca’s approval in the third or later-line setting in ovarian cancer. The company took the decision based on discussions with the FDA regarding data from the ARIEL4 post-marketing study, which linked Rubraca to an increased risk of death. While this withdrawal became effective in the United States on Jun 10, 2022, the same is still pending in Europe. Management has already stated that the drug’s sales in this indication represent a tiny portion of total sales. An approval as a first-line treatment for ovarian cancer will likely give a boost to the drug’s sales.
Apart from ovarian cancer, Clovis is also looking to expand Rubraca’s label into additional cancer types like prostate, breast, pancreatic, bladder and gastroesophageal cancers, among others. In May 2020, the FDA approved Rubraca as monotherapy under the accelerated pathway for BRCA-mutant recurrent metastatic castrate-resistant prostate cancer (mCRPC).
A confirmatory phase III TRITON3 study evaluates Rubraca in mCRPC patients with tumors with BRCA mutations and ATM mutations. The TRITON3 study will also serve as a potential second-line label expansion for Rubraca to address mCRPC. Data from this study is expected later this year.
The company is also evaluating different Rubraca regimens for gastric cancer patients and in solid tumors with deleterious mutations in homologous recombination repair (HRR) genes. Enrollment is ongoing in the phase II LODESTAR study evaluating Rubraca in HRR patients.
Zacks Rank & Stocks to Consider
Clovis carries a Zacks Rank #3 (Hold) at present.
Some better-ranked stocks in the overall healthcare sector include
Kamada ( KMDA Quick Quote KMDA - Free Report) , Morphic ( MORF Quick Quote MORF - Free Report) and Sesen Bio ( SESN Quick Quote SESN - Free Report) , each sporting a Zacks Rank #1 (Strong Buy) at present. You can see . the complete list of today’s Zacks #1 Rank stocks here
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