AstraZeneca PLC and Merck & Co. Inc.'s medicine Lynparza has been approved by the U.K.'s National Institute for Health and Care Excellence as a maintenance treatment for certain patients with ovarian and other cancers.
In draft guidance, the drug pricing watchdog recommended Lynparza tablets for patients with a high-grade epithelial ovarian, fallopian tube or peritoneal cancer who have undergone at least three prior platinum-based chemotherapy treatments and who carry mutations in the genes known as BRCA1 or BRCA2.
The approval is based on phase 2 and phase 3 trials, including the Solo-2 study, which tested patients with the BRCA gene mutation and showed that Lynparza, also known as olaparib, delayed disease progression by about 13.6 months compared with placebo.
The agency said that while olaparib is a cost-effective option for the patients who have gone through at least three prior platinum-based chemotherapy rounds, it does not meet NICE's end-of-life criteria for patients who have had two prior rounds of platinum-based chemotherapy. But because Lynparza could potentially be cost-effective in treating patients that have had two prior rounds of chemo, depending on the outcome of further clincial trials, those patients can use the Cancer Drugs Fund to pay for the treatment.
The medicine was granted priority review in the U.S. as initial maintenance therapy for patients with advanced ovarian cancer on Jan. 13, and in July 2019 it was approved for National Health Service use by the U.K.'s drug pricing watchdog for the same indication.
The therapy is considered to have the potential to cure the disease in some people if given at an early stage, before the first recurrence.
The AstraZeneca-Merck cancer drug is approved in the EU, U.S. and Japan as maintenance therapy for certain ovarian cancer patients. Lynparza is also approved in the U.S. to treat patients with BRCA-mutated breast cancer.
The U.K.'s AstraZeneca and Kenilworth, N.J.-based Merck are developing Lynparza under an $8.5 billion collaboration the companies entered in 2017.