Although we don't believe in timing the market or panicking over market movements, we do like to keep an eye on big changes -- just in case they're material to our investing thesis.
What: Shares in Clovis Oncology (NASDAQ:CLVS) vaulted higher by as much as 10% earlier today, after the company announced that it had received FDA breakthrough therapy designation for one of its drugs.
So what: The FDA granted breakthrough therapy designation to Clovis' rucaparib for use as a treatment for advanced ovarian cancer in patients who have received at least two prior platinum-based therapies and who have mutations to the BRCA gene.
More than 90% of ovarian cancer cases are caused by uncontrolled growth of epithelial cells on the surface of the ovary. In cases where high-grade serous carcinoma -- a variation of the cancer that accounts for 70% of epithelial ovarian cancer cases -- isn't diagnosed early enough for surgery, there remains a high unmet need for new treatment options.
The FDA's decision comes following the release of data from a phase 2 trial of rucaparib in which at least 65% of patients treated with rucaparib responded to it.
Now what: The nod clears the way for intense guidance from the FDA on the best way for Clovis to approach its new drug application. It also provides a fast-track pathway that could help this drug reach the market quickly.
Currently, Clovis expects that it will file for FDA approval in 2016. If so, that would be good news for patients. Roughly 22,000 American are diagnosed with ovarian cancer annually, and despite advances, ovarian cancer remains the fifth leading cause of cancer-related death among women.
Although a lot could still happen that could derail rucaparib, this news is a very good step in the right direction for Clovis, and that suggests that investors interested in companies developing next-generation cancer therapies might want to keep this on a short list of names to watch.