Clovis Oncology’s Ovarian Cancer Drug Approved by FDA

A new ovarian cancer drug was just approved by the U.S. Food and Drug Administration (FDA) — and not only did they approve it, but they accelerated its approval.

The approval from the FDA comes two months ahead of schedule.

This new monotherapy treatment is called Rubraca and comes from the pharmaceutical company Clovis Oncology (NASDAQ: CLVS). The company was founded in 2009 and is headquartered in Boulder, Colorado. It mostly markets and produces products for oncological treatment.

Rubraca will be used to treat women with advanced ovarian cancer who have the specific gene mutation (deleterious BRCA) and who have also been treated with two or more chemotherapies.

The treatment is a PARP inhibitor.

A PARP helps repair DNA when it becomes damaged. In this instance, for treating relapsed ovarian cancer, the PARP inhibitor will help keep cancer cells from repairing their damage to DNA. And if they’re unable to repair their damage, that means those cancer cells will die and the tumor won’t be able to survive.

Rubraca is the first PARP inhibitor to be approved by the FDA for ovarian cancer.

And it’ll also be a first for Clovis…

Rubraca will be Clovis’s first approved product in its portfolio.

An Optimistic Future

Sue Friedman, Executive Director of Facing Our Risk of Cancer Empowered, had this to say:

Ovarian cancer is one of the most difficult cancers to detect. For this reason, most women who develop ovarian cancer are diagnosed with advanced disease…

According to the National Cancer Institute, 22,280 women will be diagnosed with ovarian cancer in 2016, and an estimated 14,240 women will die from the disease.

For a broader view, the American Cancer Society has reported that a woman’s risk of being diagnosed with ovarian cancer during her lifetime is about 1 in 75, and her lifetime chance of dying from ovarian cancer is about 1 in 100.

This treatment comes at a time when it seems almost impossible to overcome ovarian cancer — when it’s finally detected, the cancer cells have already advanced.

Rubraca has the opportunity to change that.

PARP inhibitors like Rubraca are an exciting and optimistic advancement for ovarian cancer treatment, especially for patients who have relapsed and have already endured multiple chemotherapies.

The National Cancer Institute reports that 39% of women who inherit a harmful BRCA1 mutation and 11–17% of women who inherit a harmful BRCA2 mutation will develop ovarian cancer by age 70.

Introducing a new drug that’ll treat relapsing ovarian cancer patients will benefit many lives, while also paving the road for even more cancer research and clinical trials that’ll involve PARP inhibitors as a way to treat cancer.

Reaction From the News

The news of the FDA’s accelerated approval of Rubraca was announced on Monday, December 19th, and that news gave Clovis Oncology’s stock a giant boost. It even reached a 52-week high of $46.97.

Clovis opened Monday at $37.20 and ended the day at $40.48 — an 8% gain for the day.

The stock surged to $46.97 during midday, but as the day came to a close, the price began to decline.

Clovis Oncology (CLVS) Chart - Dec 19 2016

Clovis has a market cap of $1.43 billion. Its research and development expenses totaled $54.3 million for the third quarter of 2016 compared to 2015’s third quarter, which totaled $76.1 million. The decrease in R&D expenses could be due to the offset with development and launch programs for Rubraca.

The approval of the drug two months ahead of schedule will definitely benefit the drug’s marketing efforts, in addition to the other obvious benefit: having the ability to treat advanced ovarian cancer.

Rubraca is one of a kind in its market, and the company has already experienced an increase in stock prices from the news. This is its breakthrough drug.

But it isn’t stopping there. Clovis plans on exploring further…

Clovis Oncology’s President and CEO, Patrick J. Mahaffy, said:

Importantly, we remain focused on exploring rucaparib more broadly, and expect several studies to initiate this quarter, including the TRITON2 study in prostate cancer, the ARIEL4 confirmatory study in ovarian cancer and investigator-sponsored studies exploring rucaparib as maintenance therapy in gastroesophageal cancer and also in combination with bevacizumab in ovarian cancer.

Until next time,

Jennifer Clark
Pro Trader Today