Lynparza is currently being investigated as maintenance therapy in patients with germline BRCA-mutated (gBRCAm) metastatic pancreatic cancer whose disease has not progressed following first-line platinum-based chemotherapy.
Pancreatic cancer is a rare, life-threatening disease that accounts for about 3% of all cancers in the US Due to the late onset of symptoms, patients are often diagnosed after the cancer has progressed to locally advanced or metastatic stages of the disease. Five-year survival rates remain low in the US at 8.5%.
This is the fourth ODD in the US for Lynparza. ODD status was granted for the treatment of ovarian cancer in October 2013.
Earlier this year, an amended ODD status was granted to include both fallopian tube and primary peritoneal cancers following the expanded US approval of Lynparza in August 2017 for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy.
The FDA grants ODD status to medicines intended for the treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the US.
Through the ODD program, the FDA provides incentives for pharmaceutical companies to develop products for rare diseases.
The use of Lynparza in pancreatic cancer is being assessed in the ongoing Phase 3 POLO trial, which is investigating Lynparza as maintenance monotherapy versus placebo in patients with gBRCAm metastatic pancreatic cancer whose disease has not progressed following first-line platinum-based chemotherapy. Results from the POLO trial are expected in the first half of 2019.
Myelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML): Occurred in
UroGen's UGN-103 IND accepted by FDA for bladder cancer treatment
MaaT Pharma reveals positive 18-month data for MaaT013 in GI-aGvHD
Innate Pharma advances Sanofi-developed NK cell engager to Phase 2 for blood cancer patients
Soligenix receives orphan drug designation from FDA for active ingredient in SuVax
Candel Therapeutics granted FDA Orphan Drug Designation for CAN-2409 in pancreatic cancer treatment
Lipogems completes patient enrolment in ARISE I US FDA IDE study
Amylyx Pharmaceuticals' AMX0035 shows promising impact on Wolfram syndrome symptoms
Roche attains CE Mark for first companion diagnostic for HER2-low metastatic breast cancer
Cadrenal Therapeutics' tecarfarin receives US FDA Orphan Drug Designation
BioCity Biopharma's BC2027 Phase one study IND application receives US FDA approval
Seres Therapeutics completes patient enrollment for SER-155 Phase 1B trial