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 The U.S. Food and Drug Administration (FDA) approved the drug's use
as a first-line maintenance therapy for patients with BRCA gene
mutations whose cancer had spread beyond the pancreas and whose
tumors did not worsen after chemotherapy of at least 16 weeks, the
British drugmaker said on Monday.
Mutations in BRCA genes impair the ability to repair DNA damage and
are typically linked with breast and ovarian cancers, but can occur
in other cancers as well.
Lynparza belongs to a class of drugs known as PARP inhibitors, which
block what is left of the DNA repair mechanism so cancer cells fail
to replicate and a tumor cannot sustain itself.
The drug is now the only approved medicine in biomarker-selected
patients with advanced pancreatic cancer.
It is already approved for ovarian and breast cancers, and its
latest approval underscores the potential of PARP inhibitors for use
in newer indications.
"Metastatic pancreatic cancer patients have been waiting a long time
for new therapy options for their devastating disease," said Julie
Fleshman, chief executive officer of Pancreatic Cancer Action
Network.
Pancreatic cancer is deadly as most patients are diagnosed in
advanced stages.
It is expected to claim the lives of nearly 46,000 Americans in
2019, according to the American Cancer Society.
The widely expected approval follows a panel recommendation this
month after a study showed Lynparza helped pancreatic cancer
patients go nearly twice as long without their disease worsening
than those who received a placebo.
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Lynparza became the first marketed PARP drug with a U.S. approval
for ovarian cancer in 2014 and is key to AstraZeneca's push in
oncology and sustaining the company's turnaround.
Other approved PARP inhibitors include GSK's Zejula, Pfizer's
Talzenna and Clovis Oncology's Rubraca, but Lynparza sales dwarf
their numbers.
AstraZeneca's PARP treatment brought in $847 million in sales for
the nine months ended Sept. 30. Prior to the latest approval,
analysts forecast average sales of $3.1 billion in 2023 for Lynparza.
The London-listed drugmaker has numerous trials lined up for
Lynparza and in various combination treatments across different gene
pools.
This is also AstraZeneca's second big win this month after the FDA
approved its and Daiichi Sankyo's drug to treat an advanced form of
breast cancer, four months ahead of schedule.
(Reporting by Pushkala Aripaka in Bengaluru; Editing by Shailesh
Kuber and Jason Neely)
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