The Food and Drug Administration approved the first PARP inhibitor for the maintenance treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated metastatic pancreatic adenocarcinoma.
The Food and Drug Administration (FDA) approved Lynparza (olaparib) for the maintenance treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated metastatic pancreatic adenocarcinoma whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen, according to AstraZeneca and Merck.
Of note, this is the only PARP inhibitor approved in this patient population. Moreover, the FDA action follows a positive recommendation from the agency’s Oncologic Drugs Advisory Committee, which previously voted 7 to 5 in favor of the approval.
“Metastatic pancreatic cancer patients have been waiting a long time for new therapy options for their devastating disease. Today’s approval of Lynparza provides an exciting new treatment option for patients with germline BRCA-mutated metastatic pancreatic cancer,” Julie Fleshman, president and CEO of the Pancreatic Cancer Action Network, said in a press release.
The agency based its decision on results from the pivotal phase 3 POLO trial, which demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (the time from treatment to disease progression or worsening) with Lynparza. The agent nearly doubled the time patients lived without disease progression or death to a median of 7.4 months vs. 3.8 months on placebo.
The most common side effects were fatigue/asthenia (60%), nausea (45%), abdominal pain (34%), diarrhea (29%), anemia (27%), decreased appetite (25%), constipation (23%), vomiting (20%), back pain (19%), arthralgia (15%), rash (15%), thrombocytopenia (14%), dyspnea (13%), neutropenia (12%), nasopharyngitis (12%), dysgeusia (11%) and stomatitis (10%). The most common grade 3 or higher side effects included anemia (11%), fatigue/asthenia (5%), decreased appetite (3%), abdominal pain (2%), vomiting (1%) and arthralgia (1%).
“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, executive vice president and head of the oncology business unit at AstraZeneca, said in the release.
Check back later on what you need to know about this approval.