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Tazverik (tazemetostat) / Epizyme, EisaiEpizyme announces U.S. FDA accelerated approval of Tazverik (tazemetostat) for relapsed/refractory follicular lymphoma (Epizyme Press Release) - Jun 18, 2020 - "Epizyme...announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for TAZVERIK™ (tazemetostat) for the following two distinct follicular lymphoma (FL) indications: Adult patients with relapsed or refractory FL whose tumors are positive for an EZH2 mutation as detected by an FDA-approved test and who have received at least two prior systemic therapies. Adult patients with relapsed or refractory FL who have no satisfactory alternative treatment options."HQP1351 / Ascentage PharmaAscentage Pharma Submits Its First New Drug Application to National Medical Products Administration, for HQP1351, the First Third-Generation BCR-ABL Inhibitor in China (PRNewswire) - Jun 18, 2020 - "Ascentage Pharma...today announced that Guangzhou Healthquest Pharma Co., Ltd, a wholly-owned subsidiary of Ascentage Pharma's, has submitted a New Drug Application (NDA) to the Center for Drug Evaluation (CDE) of China National Medical Products Administration (NMPA) for HQP1351 for the treatment of patients with T315I-mutant chronic phase chronic myeloid leukemia (CP-CML) and accelerated phase CML (AP-CML)."Elunate (fruquintinib) / Chi-MedChi-Med Announces Fruquintinib Granted U.S. FDA Fast Track Designation for Metastatic Colorectal Cancer (GlobeNewswire) - Jun 18, 2020 - "Hutchison China MediTech Limited...today announces that the U.S. Food and Drug Administration ('FDA') has granted Fast Track Designation for the development of fruquintinib, for the treatment of patients with metastatic colorectal cancer ('mCRC')...Chi-Med is initiating a Phase III registration study, known as the FRESCO-2 study, in refractory mCRC in the U.S., Europe and Japan...FRESCO-2 is expected to start enrolling patients in mid-2020..."LNS8801 / Linnaeus TherapLinnaeus Therapeutics Granted U.S. FDA Fast Track Designation for LNS8801 for the Treatment of Patients with Metastatic or Unresectable Melanoma Who Have Progressed on Anti-PD-1/L1 Therapy (PRNewswire) - Jun 18, 2020 - "Linnaeus Therapeutics, Inc...announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for LNS8801 for the treatment of patients with metastatic or unresectable melanoma who have progressed on or after anti–programmed cell death receptor or ligand (anti–PD-1/L1) therapy....Linnaeus is currently evaluating LNS8801 in a phase 1 clinical trial in patients with advanced cancer. The company expects to identify the recommended phase 2 dose this summer and to begin its phase 2 program evaluating LNS8801 as a monotherapy and in combination with targeted therapies in early fall."Brukinsa (zanubrutinib) / BeiGene, MedisonBeiGene Announces European Medicines Agency Acceptance of its Marketing Authorization Application for BRUKINSA (Zanubrutinib) for the Treatment of Patients with Waldenström’s Macroglobulinemia (GlobeNewswire) - Jun 18, 2020 - "BeiGene, Ltd…announced that its marketing authorization application (MAA) for BRUKINSA® (zanubrutinib) for the treatment of patients with Waldenström’s macroglobulinemia (WM) who have received at least one prior therapy or as first-line treatment for patients unsuitable for chemo-immunotherapy has been validated for regulatory review by the European Medicines Agency (EMA)."
