USFDA nod to AstraZeneca and Merck’s Lynparza to treat pancreatic cancer.
AstraZeneca and Merck & Co’s ovarian cancer drug, Lynparza, received U.S. regulatory approval for the treatment of advanced pancreatic cancer, cementing its position in a niche class of cancer treatments.
The U.S. Food and Drug Administration (FDA) approved the Lynparza to treat pancreatic cancer as a first-line maintenance therapy for patients with BRCA gene mutations.
The cancer of whose 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 ability to repair DNA damage. Lynparza belongs to a class of drugs known as PARP inhibitors.
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It block what is left of the DNA repair mechanism so cancer cells fail to replicate and a tumour cannot sustain itself.
An FDA panel earlier this month recommended approving Lynparza to treat pancreatic cancer after a late-stage study.
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It showed the drug helped patients go nearly twice as long without their disease worsening than those who received a placebo.
BRCA mutations are typically linked with breast and ovarian cancers, but can occur in other cancers as well.
Lynparza is already approved for ovarian and breast cancers, and its latest approval underscores the potential of PARP inhibitors for use in newer indications.
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The drug is now the only approved medicine in biomarker-selected patients with advanced pancreatic cancer.
The treatment was the first marketed PARP drug with a U.S. approval for ovarian cancer in 2014.
AstraZeneca has numerous trials lined up for Lynparza and in various combination treatments.
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