Clovis Oncology (NASDAQ:CLVS)

On Monday, Clovis Oncology stock closed higher by 9% after it announced that the FDA had approved its drug. The drug in question is known as rucaparib - to be marketed as Rubraca. This was for early approval of rucaparib, which is used to treat patients with advanced ovarian cancer. The stock had a little trouble maintaining all of its gains throughout the day. That's because it gave back a lot of of what it had gained initially. The stock was initially trading higher by as much as 22%, but gave most of the gains back to only close higher by 9%.

CLVS Big Surprise

The FDA approval of rucaparib came in a lot sooner than what was expected. That's because the FDA granted approval using a program known as Accelerated Approval. This is where a drug can garner earlier approval if it treats a serious or life-threatening disease. This is based on clinical data that meets typical approval standards and helps those with no other treatment options. First off, the FDA establishes what is known as a surrogate endpoint that is used to determine clinical benefit. In other words, such an endpoint would be used to determine if the drug is efficacious enough to warrant early approval. The FDA wasn't supposed to decide on approval for rucaparib until February. That's why this early approval came as such a huge surprise.

Clinical Trial

The phase 3 trial showed some substantial efficacy, which is why the drug has been approved early. In addition, the drug targets a patient population with a huge unmet medical need. There were two single-arm trials done to prove efficacy of rucaparib. The two trials recruited up to a total of 160 patients with advanced ovarian cancer. The ovarian cancer patients recruited into the trial had to meet another requirement. That requirement is that they had to have the BRCA mutation in order to enroll into the clinical trial. That wasn't the only requirement though, because patients also had to have been treated with two prior chemotherapy treatments. The final result of the trial was that 54% of patients experienced complete or partial shrinking of their tumor over a median of 9.2 months.

Looking Forward

This FDA accelerated approval for rucaparib is good because now CLVS can go after additional indications. Other indications being targeted include prostate cancer, breast cancer, and gastroesophageal cancer. This early approval for ovarian cancer bodes well for the company and its stock. The stock has been beaten down pretty badly in the past for pipeline setbacks, but now it seems like things are finally starting to shape up for it. Ovarian cancer is a large unmet medical need because not many treatment options exist for it. At least 22,000 women are diagnosed with ovarian cancer each year. Out of all the patient population, at least 15% to 20% have the BRCA mutation needed to take the drug rucaparib. The fact that its a rare form of cancer means that the whole market of the BRCA  mutation will belong to CLVS. That means that the future is very bright indeed for the company.

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