The U.K.'s National Institute for Health and Care Excellence has recommended Clovis Oncology Inc.'s Rubraca to treat women with ovarian cancer, in a reversal of its earlier decision after the U.S.-based company cut the price of the drug.
Women in the U.K. with relapsed ovarian, fallopian tube or peritoneal cancer that has responded to platinum-based chemotherapy can now be offered Rubraca, also known as rucaparib. The U.K. pricing watchdog said the new treatment, which stops cancer cells from repairing themselves, will be immediately available through the Cancer Drugs Fund and could benefit about 1,350 women in England.
In clinical trials, rucaparib was shown to prevent the progression of cancer for twice as long as the placebo treatment — a median of 10.8 months versus 5.4 months — although overall survival data is not yet available. The medicine belongs to a class of drugs called PARP-inhibitors, or poly ADP ribose polymerase, which are targeted therapies that kill cancer cells by blocking enzymes that allow cells to repair DNA.
Other PARP inhibitors include GlaxoSmithKline PLC's Zejula, or niraparib, and AstraZeneca PLC's Lynparza, also known as olaparib, both of which recently unveiled highly anticipated data showing a jump in survival for women with ovarian cancer without the disease progressing.
Ovarian cancer, the fifth most common cancer in the world, is difficult to detect and often only diagnosed once it has reached an advanced stage. PARP inhibitors offer promising new treatment options for patients who, despite responding well to first-line treatment, usually relapse within two years of diagnosis.
"I think PARP inhibitors have been under-used and under-appreciated," GSK's head of oncology, Axel Hoos, said in an interview on the sidelines at ESMO. "We said that when we acquired Tesaro — that was one of our reasons for acquiring the company — because we feel that this class of drugs can do a lot more than has been done with them so far."
NICE recently recommended GSK's Zejula for maintenance treatment in ovarian cancer and AstraZeneca's Lynparza for those with a BRCA mutation, a genetic mutation linked with breast, ovarian and prostate cancers.
"Many people with advanced ovarian cancer experience recurrent disease, which requires multiple rounds of chemotherapy. Rucaparib offers patients a new treatment option to help prevent cancer growth, delaying the need for further chemotherapy and the associated side-effects," said NICE's Meindert Boysen, in a statement. "We're therefore pleased with the positive response from the company that has led to rucaparib being approved for use in the Cancer Drugs Fund. This will allow patients to access the treatment immediately, while more evidence can be collected on its overall survival benefit."
