AstraZeneca nabs priority review for Lynparza in prostate as PARP inhibitors expand to more cancers
Lynparza keeps rolling.
Three weeks after the FDA cleared the AstraZeneca drug as a first-line treatment of a particular form of advanced pancreatic cancer, the agency has granted priority review for the drug as a second-line treatment of a particular form of advanced prostate cancer. A PDUFA date is set for the second quarter of 2020.
The news is another notch in the belt for an R&D program and an oncology pipeline that was struggling just three years ago. Lynparza, a PARP inhibitor, and Imfinzi, AstraZeneca’s CTLA4 immunotherapy, will each finish 2019 with over $1 billion sales, and they only continue to expand their potential market. Last week, a Lynparza combo got priority review for a form of advanced ovarian cancer and yesterday an Imfinzi combo earned orphan designation for liver cancer.
If approval in advanced prostate cancer comes, it would also mark a step for PARP inhibitors as a class. Originally developed for ovarian cancers with a BRCA mutation, the inhibitors have been shown effective in a growing number of cancers. First, that meant breast cancers with the same mutation, but studies have since shown effectiveness in other solid tumors with the mutation and even — for reasons still unclear — some without it.
This indication would be the second approval outside ovarian or breast cancer, after last month’s approval for germline BRCA-mutated metastatic adenocarcinoma of the pancreas. The precise indication now before the FDA is metastatic prostate cancer with HRR mutations — mutations to the DNA’s repair processes, including BRCA — that was resistant to medical castration.
The submission is based on the 387-person, Phase III PROfound trial AstraZeneca unveiled at ESMO. It showed that Lynparza extended the median amount of time patients lived without their disease progressing from 3.5 months to 5.8 months. (For the BRCA subset, it was 3.6 months to 7.4 months).
AstraZeneca did not announce any overall survival data, but the FDA does not always demand it; Lynparza was approved for pancreatic cancer despite showing no survival benefit.
Merck partnered with AstraZeneca on commercializing the drug and earns half of all profits.