Clovis Oncology Inc (NASDAQ:CLVS) is on a tear thanks to its cancer drug Rubraca receiving a “breakthrough therapy” designation from the US Food and Drug Administration.
This recognition means that the review of Rubraca by the FDA for the treatment of BRCA ½ mutated metastatic castration-resistant prostate cancer will likely be faster than the usual course of action.
Optimistic about the news, investors sent Clovis shares up 11.9% to $32.60 in Tuesday’s afternoon trade.
Metastatic castration-resistant prostate cancer is a variety of cancer that has spread beyond the prostate. Referred to as mCRPC, it is incurable and usually associated with a poor prognosis, Clovis said.
Oppenheimer analyst Leah Rush Cann’s analysis shows a breakthrough therapy designation can reduce FDA-approval time by 40%, while only 20% of sponsors receive the designation.
Rush Cann’s financial outlook for Clovis remains unchanged for 2017-2022 and Rubraca as a treatment for prostate cancer is not being factored into her financial outlook.
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“We have not included any sales or earnings in our outlook from Rubraca in the prostate setting by 2022 due to its stage of development,” she wrote in a note to investors.
“However, we are encouraged by its receiving Breakthrough Therapy Designation,” she added.
Rubraca, which is a small molecule PARP inhibitor, has already been designated a breakthrough therapy by the FDA as a treatment for advanced cases of ovarian cancer.
Rush Cann is keeping a Perform rating on Clovis, but thinks Rubraca's adoption as a drug to fight ovarian cancer "could be slower than estimated".
The current breakthrough-therapy designation was granted to Rubraca based on initial results from the phase 2 Triton2 study of the therapy in men with advanced prostate cancer with BRCA ½ mutations and other harmful mutations of repair genes.
The Triton2 clinical study results will be presented for the first time at the 2018 European Society for Medical Oncology Congress in Munich on October 19 through the 23rd and later in the month, at the 25th Annual Prostate Cancer Foundation Scientific Retreat in California.