* First of its kind to get FDA okay to treat pancreatic
cancer
* Lynparza belongs to class of treatments called PARP
inhibitors
* Drug had sales of $847 mln in 9 months to September
(Recasts, adds details, executive comment)
By Pushkala Aripaka
Dec 30 - AstraZeneca and Merck's ovarian
cancer drug Lynparza has received U.S. regulatory approval for
the treatment of advanced pancreatic cancer, cementing its lead
in a niche category of cancer treatments.
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 tumours 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 tumour 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.
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)
Astrazeneca (AZN)
Glaxosmithkline (GSK)
