AstraZeneca (AZN - Free Report) and Merck (MRK - Free Report) announced that the FDA has approved their PARP inhibitor, Lynparza, as maintenance treatment for BRCA-mutated (gBRCAm) metastatic pancreatic adenocarcinoma (pancreatic cancer) in patients whose disease has progressed at least 16 weeks following first-line platinum-based chemotherapy regimen. Patients will be selected based on an FDA-approved companion diagnostic for Lynparza.
With this approval, Lynparza becomes the first PARP inhibitor to be approved for treating biomarker-selected patients with advanced pancreatic cancer. The decision was expected as the FDA Oncologic Drugs Advisory Committee had recommended the approval earlier this month. The drug is under review in Europe for similar indication, with a decision expected in the first half of 2020.
Lynparza is already approved for multiple indications in advanced ovarian cancer and metastatic breast cancer.
Shares of AstraZeneca have rallied 31.7% in the past year compared with the industry’s increase of 12%.
The recent approval for Lynparza in pancreatic cancer was based on positive data from the phase III POLO study. Data from the study showed that treatment with Lynparza tablets (300mg twice daily) led to statistically-significant and clinically-meaningful improvement in the primary endpoint of progression-free survival compared to placebo. Patients treated with Lynparza achieved a 47% reduction in risk of disease progression or death compared to placebo.
Per the press release, 460,000 new patients were diagnosed with pancreatic cancer globally in 2018. Most patients are diagnosed with the disease at metastatic stage. Current treatment options mostly include surgery, chemotherapy and radiotherapy, which represent a significant opportunity for Lynparza.
In the first nine months, sales from the drug grew 93% year over year to $847 million on the back of several label expansions, especially first-line ovarian cancer. AstraZeneca expects it to reach blockbuster status this year.
The drug is also being evaluated in different studies for a range of tumor types including prostate and gastric cancers as well as earlier-line settings for breast cancer.
Other FDA-approved PARP inhibitors include Clovis Oncology’s Rubraca, Glaxo’s (GSK - Free Report) Zejula and Pfizer’s (PFE - Free Report) Talzenna. Lynparza enjoys advantage in the PARP inhibitor segment as it is approved for the most number of oncology indications.
AstraZeneca currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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