Oncology

FDA Grants Priority Review for Kite’s BLA for KTE-X19 for Treatment of Relapsed or Refractory Mantle Cell Lymphoma

SANTA MONICA, Calif.–(BUSINESS WIRE)–Kite, a Gilead Company (Nasdaq: GILD), today announced that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) and granted Priority Review designation for KTE-X19, an investigational chimeric antigen receptor (CAR) T cell therapy for the treatment of adult patients with relapsed …

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Janssen Submits sBLA to the FDA for Darzalex Combination Regimen for Treatment of Relapsed/Refractory Multiple Myeloma

RARITAN, N.J., Feb. 10, 2020  — The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking approval of DARZALEX® (daratumumab) in combination with Kyprolis® (carfilzomib) and dexamethasone (DKd) for relapsed/refractory multiple myeloma. The sBLA is supported …

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Blueprint Medicines Announces PDUFA Date Extension for NDA of Avapritinib for Treatment of Fourth-Line Gastrointestinal Stromal Tumor

CAMBRIDGE, Mass., Feb. 6, 2020 /PRNewswire/ — Blueprint Medicines Corporation (NASDAQ: BPMC), a precision therapy company focused on genomically defined cancers, rare diseases and cancer immunotherapy, today announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) date for its New Drug …

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CD19 CAR NK-cell Therapy Achieves 73% Response Rate in Patients with Leukemia and Lymphoma

According to results from a Phase I/IIa trial at The University of Texas MD Anderson Cancer Center, treatment with cord blood-derived chimeric antigen receptor (CAR) natural killer (NK)-cell therapy targeting CD19 resulted in clinical responses in a majority of patients with relapsed or refractory non-Hodgkin’s lymphoma (NHL) and chronic lymphocytic leukemia (CLL), …

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Breakthrough Study Makes Cancer Detection Possible with a Simple Blood Test; Introduces a New Systemic Hallmark of Cancer

MUMBAI, India, Feb. 5, 2020 /PRNewswire/ — A new study by scientists from India, USA, and UK has presented clinical evidence for an innovative test that can detect clusters of cancer cells in the blood of asymptomatic individuals as a non-invasive screening and diagnostic test. The test could make cancer …

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Genprex to Focus Its Clinical Efforts on Oncoprex in Combination Therapy with Osimertinib for Non-Small Cell Lung Cancer

AUSTIN, Texas & CAMBRIDGE, Mass.–(BUSINESS WIRE)–Genprex, Inc. (“Genprex” or the “Company”) (Nasdaq: GNPX), a clinical-stage gene therapy company utilizing a unique, non-viral proprietary platform designed to deliver tumor suppressor genes to cancer cells, today provides a clinical update and focus for its Oncoprex™ immunogene therapy program for 2020, prioritizing the development of …

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Moleculin to Seek Accelerated FDA Approval and Plans for Pivotal Phase 2 AML Trial

HOUSTON, Feb. 5, 2020 /PRNewswire/ — Moleculin Biotech, Inc., (Nasdaq: MBRX) (“Moleculin” or the “Company”), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors, today announced it intends to discuss with the FDA and EMA (European Medicines Agency) plans to conduct a single …

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United Therapeutics’ Unituxin Fails to Meet Primary Endpoint in Phase 2/3 Study in Small Cell Lung Cancer

SILVER SPRING, Md. and RESEARCH TRIANGLE PARK, N.C., Feb. 3, 2020 /PRNewswire/ — United Therapeutics Corporation (Nasdaq: UTHR) today announced topline results from the phase 2/3 DISTINCT clinical study evaluating Unituxin® (dinutuximab) Injection added to irinotecan compared to irinotecan or topotecan alone in patients with relapsed or refractory small cell lung cancer (SCLC). The DISTINCT trial …

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Roche’s Tecentriq Fails to Meet Primary Endpoint in Phase 3 Study in Patients with Muscle-Invasive Urothelial Cancer

Basel, 24 January 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the Phase III IMvigor010 study evaluating Tecentriq® (atezolizumab) as an adjuvant (after surgery) monotherapy treatment did not meet its primary endpoint of disease-free survival (DFS) compared to observation in people with muscle-invasive urothelial cancer (MIUC). Safety …

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Exelixis Announces Results for Combination of Cabozantinib and Nivolumab with or without Ipilimumab in Advanced Hepatocellular Carcinoma

ALAMEDA, Calif.–(BUSINESS WIRE)–Exelixis, Inc. (NASDAQ: EXEL) today announced phase 1/2 clinical trial results from the combination of cabozantinib (CABOMETYX®) and nivolumab (Opdivo®) with or without ipilimumab (Yervoy®) in advanced hepatocellular carcinoma (HCC). Data from the cabozantinib combination cohort of the CheckMate 040 trial will be presented on Friday, January 24 during …

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