AstraZeneca PLC AZN and partner Merck MRK announced that the European Commission has approved their PARP inhibitor Lynparza for the treatment of patients with germline BRCA-mutated (gBRCAm) metastatic pancreatic cancer.
Following this development, Lynparza becomes the first PARP inhibitor to get the nod for treating biomarker-selected patients with advanced pancreatic cancer.
The approval in the EU was based on positive data from the phase III POLO study, which evaluated Lynparza as maintenance monotherapy versus placebo. Data from the study showed that treatment with Lynparza nearly doubled median progression-free survival after first-line chemotherapy in the given patient population as compared to placebo.
Per the company, treatment with Lynparza nearly doubled the time patients with gBRCAm metastatic pancreatic cancer lived without disease progression or death to a median of 7.4 months as compared to 3.8 months on placebo. This safety and tolerability profile of Lynparza in the study was similar to previous studies.
Last December, Lynparza was approved by the FDA for a similar indication in the United States. The drug is already approved for multiple indications in advanced ovarian cancer and metastatic breast cancer.
Shares of AstraZeneca have increased 7.2% in the year so far against the industry’s decrease of 1.2%.
Lynparza, presently approved for three tumor types including ovarian, breast and pancreatic, was given the nod for metastatic castration-resistant prostate cancer (with HRR genetic mutations) in May 2020, which marked the drug’s approval for the fourth cancer type. Lynparza is also being evaluated in combination with Merck’s Keytruda for NSCLC.
Notably, AstraZeneca also has a profit- sharing deal with Merck for Lynparza.
In the first quarter of 2020, Lynparza sales rose 69% year over year to $397 million on the back of an expanded use in ovarian and breast cancer. Further label expansion of the drug will boost sales significantly in the future quarters. Lynparza achieved a blockbuster status in 2019.
Other FDA-approved PARP inhibitors include Clovis Oncology’s Rubraca, Glaxo’s GSK Zejula and Pfizer’s PFE Talzenna. Lynparza enjoys advantage in the PARP inhibitor segment as it is approved for most 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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