AstraZeneca said that it has received approval from the Ministry of Food and Drug Safety for an additional indication for a new tablet formulation of Lynparza, its poly ADP (adenosine diphosphate)-ribose polymerase (PARP) inhibitor, in treating ovarian and breast cancer. Until now, the Lynparza capsule was the only approved formulation in Korea.
Lynparza has just been licensed for maintenance therapy in adult patients with newly diagnosed advanced breast cancer gene (BRCA) mutations in advanced epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer who responded (partially or wholly) to platinum-based chemotherapy.
The ministry has also recognized the treatment as independent maintenance therapy for patients with platinum-sensitive recurrent highly epithelial ovarian cancer (tubal or primary peritoneal carcinoma) who responded, partially or entirely, to secondary or higher platinum-based treatments regardless of BRCA mutation.
Hospitals can now use the treatment in people with gBRCA variant HER2-negative metastatic breast cancer who underwent chemotherapy.
The new formulations approved by the ministry include 100mg and 150mg, and patients are recommended to take 300 mg a day.
With the ministry's approval, Lynparza has become the first PARP inhibitor to have a broad range of indications, including breast cancer.
Lynparza is approved as 150mg and 100mg tablets by the ministry. Lynparza should be stored at room number temperature. The recommended dose of Lynparza tablet is 300 mg (two 150 mg tablets) taken orally twice daily.
Lynparza tablet is more convenient to store and take compared to the Lynparza capsule, which had a recommended dose of 400mg (eight 50mg pills).
The ministry approved the new formulations and expanded indications for Lynparza based on three phase-3 studies -- SOLO-1, SOLO-2, and OlympiAD.
According to the SOLO-1 ovarian cancer study, Lynparza reduced the risk of disease progression and death by 70 percent compared to the placebo, and also reduced the risk of secondary disease progression and death by 50 percent. The SOLO-2 ovarian cancer study demonstrated a 70 percent reduction in disease progression and death risk for patients compared to placebo and shown comparable efficacy to existing capsule-type Lynparza.
Median progression-free survival was 19.1 months and 5.5 months for the Lynparza tablet and placebo groups, respectively.
In the OlympiAD breast cancer study, Lynparza reduced the risk of disease progression and death by 42 percent compared to standard therapy. The median progression-free survival was seven months for the Lynparza group and 4.2 months for the standard treatment.
"Lynparza's approval not only expands the area of maintenance therapy for ovarian cancers at high risk of recurrence but also provides new treatment options that target BRCA mutations in the treatment of HER2-negative metastatic breast cancers, including triple-negative breast cancers with limited treatment options," said Kim Su-yeon Kim, director of AstraZeneca's oncology business unit.
AstraZeneca will continue to identify the clinical value of PARP inhibitors in a variety of carcinomas and to advance innovation in cancer treatment, she added.