Clovis Oncology CLVS Stock News

Clovis Oncology Inc (NASDAQ: CLVS) is running for the top in the market this morning, trading on gains of more than 13% before the bell. The gains come after the company announced that it has received an FDA approval. Here’s what’s going on:

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CLVS Stock Climbs On FDA Approval

In the press release, Clovis Oncology announced that the FDA has approved FoundationOne Liquid CDx. The liquid biopsy has been approved for all solid tumors with multiple companion diagnostic indications. This is Foundation Medicine’s comprehensive liquid biopsy test. So, what’s the big deal. Why is Foundation Medicine’s FDA Approval such a big deal?

Well, the FoundationOne Liquid CDx biopsy tells physician which patients are likely to respond best to Rubraca, the recently approved CLVS treatment. The treatment was approved for adult patients with deleterious BRCA mutation-associated metastatic castration-resistant prostate cancer.

The liquid biopsy is intended to be used as a companion diagnstic to identify patients who may benefit from treatment with specific FDA-approved targeted therapy, inclucing Rubraca, which happens to be the first PARP inhibitor approved for the treatment of BRCA1/2-mutant mCRPC.

In a statement, Patrick J. Mahaffy, President and CEO at CLVS, had the following to offer:

Tumors with BRCA mutations are by far the most responsive to PARP inhibitors in metastatic castration-resistant prostate cancer, and when we started development of Rubraca for mCRPC, we knew it was important to develop a plasma-based companion diagnostic for physician and patient ease of use. What we could not have foreseen was how important a plasma-based test would be in this COVID-19 environment, in which even important procedures, such as tissue-based biopsies, can be difficult to schedule for patients. We are pleased that the FDA has approved a plasma-based companion diagnostic to identify mCRPC patients who may benefit from treatment with Rubraca.

This Is Big News

The news released by Clovis Oncology this morning proved to be overwhelmingly positive. The approval of this particular liquid biopsy has the potential to lift sales of Rubraca.

After all, if you were a physician and a diagnostic test said that your patient was going to respond well to the treatment, would you perscribe it? Of course you would, and most physicians will do the same.

As a result of the approval of this diagnostic test, we’re likely to see increased sales of Rubraca, making CLVS stock one that’s worth paying attention to.

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