Lynparza is a PARP inhibitor and the first targeted treatment to block DNA damage response (DDR) in cells/tumours harbouring a deficiency in homologous recombination repair (HRR)
The offices of MSD in Upper Gwynedd Township, Montgomery County, Pennsylvania, US. (Credit: Montgomery County Planning Commission from Wikimedia Commons)
The US Food and Drug Administration (FDA) has approved AstraZeneca and MSD’s Lynparza (olaparib) in combination with abiraterone and prednisone or prednisolone to treat adult patients with deleterious or suspected deleterious BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC).
The approval was supported by a subgroup analysis of the multi-centre phase 3 PROpel trial.
Lynparza is a PARP inhibitor and the first targeted treatment to block DNA damage response (DDR) in cells/tumours harbouring a deficiency in homologous recombination repair (HRR).
In the study, Lynparza plus abiraterone showed highly clinically meaningful improvements in both radiographic progression-free survival (rPFS) and overall survival (OS) against abiraterone alone in patients with BRCAm.
Additionally, median rPFS and median OS were not achieved for patients treated with the Lynparza combo against a median of 8 months and 23 months, respectively, for patients treated with abiraterone alone.
AstraZeneca Oncology Business Unit executive vice president Dave Fredrickson said: “There is a critical unmet need for new first-line treatment options for patients with BRCA-mutated metastatic castration-resistant prostate cancer and this approval underscores the importance of BRCA testing at metastatic diagnosis.
Lynparza is already approved in the US as monotherapy for patients with HRR gene-mutated mCRPC (BRCAm and other HRR gene mutations).
MSD Research Laboratories chief medical officer Eliav Barr said: “In PROpel, the Lynparza combination improved radiographic progression-free survival and overall survival for the subgroup of patients with BRCA-mutated metastatic castration-resistant prostate cancer.
“This approval reinforces the importance of routine testing for genetic mutations at metastatic diagnosis to help guide clinical decisions.”
In a separate development, the pharmaceutical major stopped the brazikumab inflammatory bowel disease (IBD) development programme.
Brazikumab is an investigational anti-IL-23 monoclonal antibody to treat Crohn’s disease (CD) and ulcerative colitis (UC).
The development programme included the phase 2b/3 INTREPID trial in CD and the phase 2 EXPEDITION trial in UC, and their respective open-label extension trials.