PRINCETON, N.J.--(BUSINESS WIRE)--Bristol Myers Squibb (NYSE: BMY) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of Opdivo® (nivolumab) in combination with cisplatin and gemcitabine for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma. The European Commission (EC), which has the authority to approve medicines for the European Union (EU), will now review the CHMP recommendation. The final EC decision is expected in June 2024.
FDA Approves Opdivo for First-Line Treatment of Urothelial Carcinoma
TAIPEI, Taiwan and SAN DIEGO, Dec. 04, 2023 (GLOBE NEWSWIRE) -- Polaris Group (The Company, TWSE:6550), today announced that the first patient is successfully dosed in a pivotal Phase 3 trial that...
Merck Receives Positive EU CHMP Opinion for KEYTRUDA for Biliary Tract Cancer
FDA Approves Merck’s KEYTRUDA® (pembrolizumab) Plus Gemcitabine and Cisplatin as Treatment for Patients With Locally Advanced Unresectable or Metastatic Biliary Tract Cancer
Treatment with intra-arterial (IA) gemcitabine led to an improvement in overall survival (OS) compared with continued treatment with intravenous (IV) gemcitabine plus nab-paclitaxel (Abraxane) in patients with locally advanced pancreatic cancer following sequential treatment with IV gemcitabine, nab-paclitaxel, and radiotherapy, according to data from the first interim analysis of phase 3 TIGeR-PaC trial (NCT03257033).
LEXINGTON, Mass.--(BUSINESS WIRE)--Cyteir Therapeutics, Inc. (“Cyteir”) (Nasdaq: CYT), a clinical stage oncology company, today presented results from a Phase 1 study with CYT-0851 in combination with capecitabine or gemcitabine in a poster titled “Phase 1 Results of CYT-0851, a Monocarboxylate Transporter (MCT) Inhibitor, in Combination with Capecitabine or Gemcitabine in Advanced Solid Tumors” (Abstract: 3099, Poster: 297) at the 2023 American Society of Clinical Oncology (ASCO) annual meeting in Chicago, Illinois.
Panbela Announces First Patient Enrolled in South Korea for ASPIRE Trial Studying Ivospemin (SBP-101) in Combination with Gemcitabine and Nab-Paclitaxel in Patients with Metastatic Pancreatic Ductal Adenocarcinoma
Panbela Announces Adoption of Commission Implementing Decision from the EMA for the Orphan Designation of Ivospemin (SBP-101) in Combination with Gemcitabine and Nab-Paclitaxel in Patients with Metastatic Pancreatic Ductal Adenocarcinoma
RenovoRx Announces Initial Results in Pharmacokinetic (PK) Substudy: Data on RenovoGem™ Supports Potential for RenovoTAMP® Therapy Platform to Increase Local Gemcitabine (Chemotherapy) Delivery and Decrease Side Effects of Pancreatic Cancer Treatment