Lynparza, to be approved for prostate & pancreatic cancer

The MFDS to approve in July

Lynparza, a PARP inhibitor, is expected to be approved as a treatment for prostate and pancreatic cancer in Korea.

 

According to related industries, AstraZeneca is currently expanding the license to Lynparza (Olaparib) for two indications of maintenance therapy for patients with metastatic castration-resistant prostate cancer with a homologous recombination recovery (HRR) mutation and patients with metastatic pancreatic cancer with a BRCA mutation (gBRCAm).

 

Approval is expected in July.

 

Lynparza's indication for prostate cancer was approved by the U.S.

 

FDA in May of last year and in December of 2019 for pancreatic cancer.

 

The efficacy of this drug in prostate cancer has been demonstrated in PROfound study.

 

In this study, Lynparza showed a risk ratio (HR) of 0.34 in patients with mCRPC with BRCA or ATM mutant genes compared to hormone therapy based on Abiraterone acetate or Enzalutamide, reducing the risk of death, a key efficacy evaluation index, by 66%.

 

In general, when the risk ratio is less than 1, it indicates that the risk of the experimental group decreases.

 

Lynparza recorded an HR value of 0.49 compared to the group administered with Abiraterone or Enzalutamide even in the patient group with the total HRR mutant mCRPC, reducing the risk of death by 51%.

 

The patient group with the HRR mutation included patients with 11 other gene mutations, including the BRCA 1/2, ATM, or CDK12 gene mutations.

 

Lynparza also showed statistically and clinically significant improvement in radiographic progression-free survival (rPFS).

 

In the cohort group with BRCA or ATM mutations, the median rPFS was 7.39 months for Lynparza and 3.55 months for the hormone drug-treated group.

 

In the case of pancreatic cancer, the efficacy was confirmed through the phase III POLO trial.

 

As a result of the study, the median progression-free survival (PFS) of the Lynparza first-line maintenance therapy group was 7.4 months, which reduced the risk of disease exacerbation and death by 47% compared to 3.8 months in the placebo group.

 

At both 1 year (Lynparza 34% vs.

 

placebo group 15%) and 2 years (Lynparza 22% vs.

 

placebo group 10%), progression-free survival was confirmed in patients treated with Lynparza more than twice the placebo group.

 

Lynparza was first approved for treatment of ovarian cancer.

 

The indications are for▲adult patients with ovarian cancer (including fallopian tube cancer or primary peritoneal cancer) who have responded (partial or complete) to primary and secondary platinum-based chemotherapy and ▲ patients who have received more than 3 lines of chemotherapy.