FDA approved olapanib for first-line treatment of ovarian cancer

PMLiVE reported on December 19 that AstraZeneca's Lynparza became the first PARP inhibitor approved for the first-line maintenance treatment of BRCA mutated ovarian cancer, giving the drug an advantage over its competitors. The FDA's new approval means that olapanib can be used for first-line platinum-containing chemotherapy in patients with complete or partial remission of ovarian, fallopian or primary peritoneal cancer to reduce the risk of recurrence or disease progression. At the same time, FDA has expanded the scope of application of BRAC Analysis CDx diagnosis by Myriad Genetics to screen women suitable for olapanib treatment. Supporting the new approval is the SOLO-1 trial, which updated data released at the annual meeting of the European Society of Clinical Oncology in October. The data showed that 60% of patients treated with olapanib had not progressed after three years of treatment, compared with 27% in the placebo group. Preliminary data at four years of treatment showed that the proportion was more than 50% and 50% respectively. 11%.

Olapani has expanded to this group, opening up a huge new market for this fast-growing drug. Olapani is the core of AstraZeneca's revival in oncology and the cornerstone of the company's strategic alliance with Mershadon. Evaluate Pharma expects Olapani's annual sales to reach $2.2 billion by 2024.

Olapani is well ahead of PARP inhibitor competitors, namely Zejula (niraparib) of Tesaro and Rubraca (Rucaparib) of Lovis Cancer. All three drugs have been approved for the treatment of recurrent/refractory ovarian cancer, but first-line approval has enabled Olapani to Lead its competitors in the treatment of recurrent/refractory ovarian cancer. During the acquisition of GlaxoSmithKline, Tesaro expects the third phase of Zejula's trial for first-line treatment of ovarian cancer to be published next year. Although Clovis is the third company to enter the market, it has adopted different strategies, focusing its attention on Rubraca and Bristol-Myers Checkpoint Inhibitor Nawudan for first-line maintenance treatment of ovarian cancer. Combination therapy for BRCA positive and BRCA negative patients. 

There is good news for AstraZeneca today. It comes from the SOLO-3 test, which was conducted in patients with BRCA mutation ovarian cancer who relapsed after treatment with two or more lines of drugs. Olapani has been approved for use in this patient population, but as a condition for speeding up the review, the company needs the three studies.

AstraZeneca said that this study showed that olapanib achieved significant statistical and clinical improvements in objective remission rate and progression-free survival compared with chemotherapy, although it has not yet published data. AstraZeneca Chief Medical Officer Bohen said: "This is the first test to prove that PARP Inhibitors have positive results in advanced ovarian cancer compared with chemotherapy, and advanced ovarian cancer urgently needs effective treatment. "

In another positive development, AstraZeneca today announced that two phase III trials of its newly approved anemia drug roxadustat in patients with chronic kidney disease support its efficacy. The ROCKIES test showed that in patients with CKD who depended on dialysis treatment, the oral drug had a significant improvement in hemoglobin compared with recombinant human erythropoietin for injection. In addition, the OLYMPUS trial also found similar results in patients with CKD who are less ill and have not yet started dialysis therapy, which may open up a larger market for the drug.