FDA grants Breakthrough Therapy designation to Lynparza in mCRPC

The US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for AstraZeneca’s Lynparza (olaparib) for the treatment of BRCA1/2 or ATM gene mutated metastatic Castration Resistant Prostate Cancer (mCRPC) in patients who have received a prior taxane-based chemotherapy and at least one newer hormonal agent.

The FDA criteria for Breakthrough Therapy designation require preliminary clinical evidence that demonstrates a drug may have substantial improvement on at least one clinically significant endpoint over available therapy. The decision to assign the designation for Lynparza is based on the results of the TOPARP-A Phase II trial, which found that Lynparza monotherapy in mCPRPC may offer substantial improvement over available therapies for the treatment of the biomarker-selected population with this serious and life-threatening condition. The TOPARP-A Phase II trial showed that men with prostate cancer with defective DNA damage repair mechanisms responded to Lynparza (olaparib).

“Encouraging news for patients”

Commenting on the announcement, Antoine Yver, Head of Oncology, Global Medicines Development at AstraZeneca, said: “More than 27,000 men died of prostate cancer last year in the US alone. The Breakthrough Therapy designation for Lynparza is encouraging news for patients, and their families, as there are currently very limited treatment options for metastatic Castration Resistant Prostate Cancer. We will work closely with the FDA to introduce Lynparza as a new treatment option as soon as possible.”

Lynparza is a first-in-class oral poly ADP-ribose polymerase (PARP) inhibitor that exploits tumour DNA repair pathway deficiencies to preferentially kill cancer cells. This mode of action gives the therapy the potential for activity in a range of tumour types with DNA repair deficiencies.

Lynparza has been approved by regulatory authorities in 40 countries for the maintenance treatment of women with BRCA-mutated ovarian cancer.  AstraZeneca is investigating the potential of the therapy in other PARP dependent tumours. Phase III studies in gastric cancer, pancreatic cancer and adjuvant and metastatic BRCAm breast cancers are underway, with further studies planned.