Merrimack Reports Ipsen Announcement of Approval By The US FDA of Onivyde® (Irinotecan Liposome Injection) Plus 5 Fluorouracil/Leucovorin and Oxaliplatin (NALIRIFOX) as a First-Line Treatment for Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC)
Encube Ethicals` Generic Fluorouracil Receives Approval in the U.S.
Alembic`s Generic Fluorouracil Receives Approval in the U.S.
Lower rates of diarrhea and overall bowel dysfunction were reported with the use of neoadjuvant fluorouracil and oxaliplatin (FOLFOX) vs neoadjuvant pelvic chemoradiation with fluorouracil (5FCURT) in patients with locally advanced rectal cancer, according to patient-reported outcomes (PROs) from the phase 2/3 PROSPECT trial (NCT01515787). However, lower rates of other toxicities were reported in patients treated with 5FUCRT.1
Alembic Pharmaceuticals has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Fluorouracil Injection USP, 2.5 g/50 mL (50 mg/mL) Pharmacy Bulk Vial. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Fluorouracil Injection, 2.5 g/50 mL (50 mg/mL), of Spectrum Pharmaceuticals, Inc. (Spectrum).
Enforcement Report - Week of February 1, 2023
Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the Phase 3 KEYNOTE-921 trial evaluating KEYTRUDA in combination with chemotherapy (docetaxel) compared to chemotherapy alone did not meet its dual primary endpoints of overall survival (OS) and radiographic progression-free survival (rPFS) for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC). In the study, there were modest trends toward an improvement in both OS and rPFS for patients who received KEYTRUDA plus chemotherapy compared with chemotherapy alone; however, these results did not meet statistical significance per the pre-specified statistical plan. The safety profile of KEYTRUDA in this trial was consistent with that observed in previously reported studies. Results will be presented at an upcoming medical meeting.
Ipsen (Euronext: IPN; ADR: IPSEY) announced today that the Phase III RESILIENT trial did not meet its primary endpoint of overall survival (OS) compared to topotecan. The trial is evaluating Onivyde® (irinotecan liposomal injection) versus topotecan in patients with small cell lung cancer (SCLC), who have progressed on or after platinum-based first-line therapy treatment. RESILIENT is a Phase III trial conducted in two parts; the first part read out in 2020 confirming the safety, dosing and efficacy of Onivyde; part two is evaluating the efficacy of Onivyde versus topotecan. Detailed results from the RESILIENT trial will be presented at an upcoming medical conference.
Accord Hlthcare`s Generic Fluorouracil Receives Approval In US
Merck announced that the European Commission (EC) has approved Keytruda, Merck’s anti-PD-1 therapy, in combination with platinum- and fluoropyrimidine-based chemotherapy for the first-line treatment of patients with locally advanced unresectable or metastatic carcinoma of the esophagus or human epidermal growth factor receptor 2 (HER2)-negative gastroesophageal junction (GEJ) adenocarcinoma in adults whose tumors express PD-L1 (Combined Positive Score [CPS] =10).