AstraZeneca’s Lynparza has picked up a breakthrough designation in the US as a monotherapy for certain forms of prostate cancer.
The drug is being developed for 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 (abiraterone or enzalutamide).
Lynparza’s (olaparib) breakthrough status is based on the results of the TOPARP-A Phase II trial, which indicate that it could offer substantial improvement over available therapies for the treatment of the biomarker-selected population with this serious and life-threatening condition.
The drug is an innovative, 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 Lynparza the potential for activity in a range of tumour types with DNA repair deficiencies, and it is already approved as a maintenance treatment of women with BRCA-mutated ovarian cancer.
Elsewhere, AbbVie’s venetoclax also picked up its third breakthrough status from the US Food and Drug Administration as a treatment for acute myeloid leukaemia (AML).
The designation relates to venetoclax in combination with hypomethylating agents (HMAs) for patients with untreated AML who can’t take standard high-dose chemotherapy.
AML is an aggressive form of cancer, characterised by the over-production of myeoblast white blood cells, but many patients are unable to take intensive therapy, highlighting the need for new alternative options.
Venetoclax, an inhibitor of the B-cell lymphoma-2 protein being developed by AbbVie in partnership with Genentech and Roche, has also picked up breakthrough badges as a single agent for chronic lymphocytic leukaemia in previously treated patients with the 17p deletion genetic mutation, as well as in combination with rituximab for the same patient subset.
Regulators on both sides of the Atlantic are currently reviewing a marketing application for the drug. The FDA is considering its use in patients who have received at least one prior therapy, including those with 17p deletion, while in Europe the target population is those carrying either the 17p deletion or TP53 mutations.