The U.S. Food and Drug Administration’s PDUFA dates for the last week of November 2020 include a review of Liquidia Technologies’ NDA for LIQ861 for the treatment of pulmonary arterial hypertension (PAH).
The U.S. Food and Drug Administration approved Merck’s anti-PD-1 therapy Keytruda in combination with chemotherapy for the treatment of patients with locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC) whose tumors express PD-L1 as determined by an FDA-approved test.
Shares of CStone Pharmaceuticals were up after Pfizer invested $200 million into the company for a nearly 10% stake to support the development of a checkpoint inhibitor aimed at the oncology market in China.
Opdivo Significantly Improves DFS vs. Placebo as Adjuvant Therapy for Patients with High-Risk, Muscle-Invasive Urothelial Carcinoma
Blockbusters, Clinical Trials, Disease-Free Survival (DFS), Immunotherapies, Metastatic Urothelial Carcinoma (mUC), PD-1/PD-L1 inhibitors, Placebo, Primary Endpoints, R&D, Solid Tumors, Therapeutics, TumorsBristol Myers Squibb announced that CheckMate -274, a pivotal Phase 3 trial evaluating Opdivo (nivolumab) after surgery in patients with high-risk, muscle-invasive urothelial carcinoma, met primary endpoints of improving disease-free survival (DFS) versus placebo in both all randomized patients and in patients whose tumor cells express PD-L1 ≥1% (programmed death-ligand 1).
Roche company Genentech presented data from three Phase III trials of Tecentriq (atezolizumab) in triple-negative breast cancer (TNBC) at the European Society for Medical Oncology (ESMO) Virtual Congress 2020.
Regeneron and Sanofi broke new ground in treating advanced basal cell carcinoma with their anti-PD-1 inhibitor, Libtayo.
ESMO: Merck and AstraZeneca’s 5-Year Lynparza Data in Ovarian Cancer and More
Advanced Melanoma, Advanced Squamous Carcinoma of the Anal Canal (SCAC), Biomarkers, Blockbusters, Clinical Data, Clinical Trials, Epstein-Barr Virus, European Society for Medical Oncology (ESMO), Lung Cancer, Ovarian Cancer, PD-1/PD-L1 inhibitors, Platinum-Based Chemotherapy, R&D, TherapeuticsAstraZeneca and Merck announced positive five-year follow-up data from the Phase III SOLO-1 trial which demonstrated a long-term progression-free survival benefit of Lynparza as a first-line maintenance treatment in patients with newly diagnosed, advanced BRCA-mutated ovarian cancer who were in complete or partial response to platinum-based chemotherapy.
Vaccinex Inc. will pair the company’s lead asset pepinemab with Merck & Co.’s vaunted checkpoint inhibitor Keytruda.
Bristol Myers Squibb plunked down $475 million for the exclusive license to Dragonfly Therapeutics’ interleukin-12 (IL-12) investigational immunotherapy program, including the extended half-life cytokine DF6002 as a potential treatment for solid and hematological cancers.
Published research in the peer-reviewed scientific journal Cell outlines a way to make even immunotherapy-resistant cancers treatable.