Lynparza's Fourth Approval
Merck and AstraZeneca said the FDA has approved Lynparza for the maintenance treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated pancreatic adenocarcinoma whose disease has not progressed while on at least 16 weeks of a first-line platinum-based chemotherapy regimen.
Patients will be selected for treatment based on an FDA-approved companion diagnostic for Lynparza.
Lynparza, a PARP inhibitor, has already been approved for three indications: maintenance treatment of platinum-sensitive relapsed ovarian cancer, regardless of BRCA status; first-line maintenance treatment of BRCA-mutated advanced ovarian cancer following response to platinum-based chemotherapy and gBRCAm; and HER2-negative metastatic breast cancer previously treated with chemotherapy.
FDA Goes With Adcom Verdict
FDA's Oncologic Drugs Advisory Committee, which met Dec. 17, recommended the approval of Lynparza.
"Patients with advanced pancreatic cancer historically have faced poor outcomes due to the aggressive nature of the disease and limited treatment advances over the last few decades. LYNPARZA is now the only approved targeted medicine in biomarker-selected patients with advanced pancreatic cancer," Dave Fredrickson, head of AstraZeneca's oncology division, said in a statement.
At last check, Merck and AstraZeneca shares were trading almost flat with a slight negative bias. Merck was down 0.50% at $91.06 and AstraZeneca was edging down 0.44% to $50.22.