AstraZenecom/Mesa East Lynparza (Lipjo) Japan received three approvals

AstraZeneca and Merck and Co recently announced that Lynparza, a Chinese-branded anti-cancer drug, has been approved in Japan to treat three advanced cancers: ovarian, prostate and pancreatic.
specific adaptations are: (1) Lynparza combined bevacizumab as a first-line maintenance therapy for the treatment of adult patients with HRD-positive advanced ovarian cancer who are relieved after receiving first-line chemotherapy.
(2) Lynparza is used to treat patients with degenerative resistant prostate cancer (mCRPC) with far-end metastasis and carrying BRCA gene mutation (BRCAm).
(3) Lynparza as a first-line maintenance therapy for patients with non-excisive BRCAm pancreatic cancer who have no progression after receiving first-line chemotherapy.
note that Lynparza is the first and only PARP inhibitor in Japan to be approved for treatment of mCRPC and pancreatic cancer.
the three adaptations approved by the university, based on the results of PAOLA-1, PROfound, POLO Phase 3 studies.
the study was published in the New England Journal of Medicine (NEJM).
- Ovarian cancer adaptation, based on biomarker subgroups of HRD-positive tumor patients in phase 3 PAOLA-1 study: In hd-positive patients with advanced ovarian cancer, Lynparza combined with bevalza mono-anti-drug maintenance therapy Maintenance therapy significantly reduced the risk of disease progression or death by 67% (HR-0.33 (95% CI: 0.25-0.45) and significantly extended progression-free survival (medium PFS: 37.2 months vs 17.7 months).
- Prostate Cancer Adaptation, Subgroup Analysis Based on Phase 3 PROfound Trial: In patients with BRCA1/2 mutations, Lynparza significantly improved radiological non-progressive survival compared to the standard care drug Xtandi (enzalutamide, enzyruamine) or Zytiga (abiraterone acetate, acetic acid abitron) Bit rPFS: 9.8 months vs 3.0 months) and total lifetime (mid OS: 20.1 months vs 14.4 months), reducing the risk of disease progression or death by 78% (HR-0.22, p<0.0001), and reducing the risk of death by 37% (HR-0.63).
- Pancreatic cancer adaptation, based on the results of phase 3 POLO trials: Lynparza, as a first-line maintenance therapy, nearly doubled the progression-free survival of patients with BRCAm metastatic pancreatic cancer (medium PFS: 7.4 months vs. 3.8 months), significantly reducing the risk of disease progression or death by 47 percent.
Lynparza is a pioneering, oral polyadDP ICTase (PARP) inhibitor that prioritizes the killing of cancer cells with defects in the Tumor DNA Damage Repair (DDR) path path, a model that gives Lynparza the potential to treat a wide range of types of tumors with DNA damage repair defects.
Lynparza is the world's first PARP inhibitor to be marketed and was first approved by the FDA in December 2014.
, Lynparza has been approved for seven treatments, four for ovarian cancer and two for first-line maintenance.
specifically: (1) first-line maintenance treatment of adult patients with BRCAm advanced ovarian cancer; (2) joint beval single-anti-first-line maintenance treatment of HRD-positive adult patients with advanced ovarian cancer; (3) maintenance treatment of adult patients with relapsed ovarian cancer; (4) advanced gBR Adult patients with CAM ovarian cancer; (5) adult patients treated with gBRCAm, HER2 negative (HER2-) metastatic breast cancer; (6) first-line maintenance treatment of adult patients with gBRCAm metastatic pancreatic cancer; and (7) treatment of mCRPC patients with specific gene mutations.
original source: AstraZeneca, Merck's Lynparza OK'd in Japan for cancers