Shots: The EC’s approval is based on P-III POLO study assessing Lynparza (300mg, bid) as maintenance monothx. vs PBO in 154 patients in a ratio (3:2) with gBRCAm metastatic pancreatic […]readmore
Tags : Metastatic Pancreatic Cancer
Regulatory
AstraZeneca’s Lynparza (olaparib) Receives MHLW’s Orphan Drug Designation for BRCA-Mutated
Shots: The ODD is based on P-III POLO study assessing Lynparza (300mg, bid) as maintenance monothx. vs PBO in 154 patients in a ratio (3:2) with gBRCAm metastatic PC without […]readmore
Shots: The approval follows the US FDA Oncologic drugs Advisory Committee (ODAC) on 17 Dec based on P-III POLO trial, which involves assessing of Lynparza tablets (300 mg bid) as […]readmore
Shots: The P-IIa study involves assessing of BL-8040 + Keytruda in 20 patients with metastatic pancreatic cancer who progressed after at least one prior line of chemotherapy The overall median […]readmore
Shots: Halozyme will discontinue its P-III HALO-301 study evaluating PEGPH20 in combination with gemcitabine and nab-paclitaxel (Abraxane) vs gemcitabine and nab-paclitaxel as a 1L therapy for the treatment of patients […]readmore
Shots: The P-III SEQUOIA study involves assessing of Pegilodecakin + Folfox (folinic acid, 5-FU, oxaliplatin) vs Folfox as monothx. in 567 patients with metastatic adenocarcinoma of the pancreas with diseases […]readmore
Shots: The ODD designation is based on the study results assessing devimistat + high dose cytarabine & mitoxantrone and devimistat + folfirinox in patients with r/r AML and mPC […]readmore