Oncology

FDA Approves Gavreto for the Treatment of Adults with Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has approved Gavreto™ (pralsetinib) for the treatment of adults with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) as detected by …

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Incyte Announces Pivotal GEOMETRY mono-1 Study Results of Capmatinib in Patients with METex14 Metastatic Non-Small Cell Lung Cancer Published in NEJM

WILMINGTON, Del.–(BUSINESS WIRE)–Incyte (Nasdaq: INCY) today announced that data from the Novartis pivotal Phase 2 GEOMETRY mono-1 study demonstrating that treatment with Tabrecta™ (capmatinib) resulted in positive overall response rates (ORR) with durable responses among adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that …

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Final Analysis of the Observational GioTag Study: Sequential Afatinib and Osimertinib in Patients with EGFR Mutation-Positive NSCLC

Ingelheim, Germany, 2nd September 2020 – Boehringer Ingelheim today announced the final analysis from GioTag, a real-world retrospective, observational study.  The study assessed the impact of first-line treatment with afatinib followed by osimertinib in Del19/L858R epidermal growth factor receptor mutation positive (EGFR M+) non-small cell lung cancer (NSCLC) patients with acquired …

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FDA Approves Onureg, a New Oral Therapy, as Continued Treatment for Adults in First Remission with Acute Myeloid Leukemia

PRINCETON, N.J.–(BUSINESS WIRE)–Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has approved Onureg® (azacitidine 300 mg tablets, CC-486) for the continued treatment of adult patients with acute myeloid leukemia (AML) who achieved first complete remission (CR) or CR with incomplete blood count recovery (CRi) following intensive …

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FDA Accepts and Grants Priority Review to Athenex’s NDA for Oral Paclitaxel and Encequidar in Metastatic Breast Cancer

BUFFALO, N.Y., Sept. 01, 2020 (GLOBE NEWSWIRE) — Athenex, Inc. (NASDAQ: ATNX), a global biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies for the treatment of cancer and related conditions, today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the Company’s …

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FDA Grants Fast Track and Orphan Drug Designations to VelosBio’s VLS-101 for Treatment of Mantle Cell Lymphoma

SAN DIEGO–(BUSINESS WIRE)–VelosBio Inc. (“VelosBio”), a clinical-stage biopharmaceutical company committed to developing novel, first-in-class cancer therapies targeting receptor tyrosine kinase-like orphan receptor 1 (ROR1), today announced that the U.S. Food and Drug Administration (FDA) has granted the company Fast Track and Orphan Drug designation for VLS-101 for the treatment of …

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FDA Grants Priority Review to Oncopeptides’ Melflufen for Patients with Triple-Class Refractory Multiple Myeloma

STOCKHOLM, Aug. 29, 2020 /PRNewswire/ — Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO) today announces that the US Food and Drug Administration, FDA, has granted priority review for Oncopeptides’ New Drug Application seeking approval of melflufen (INN melphalan flufenamide), in combination with dexamethasone for the treatment of adult patients with multiple …

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FDA Approves Foundation Medicine’s FoundationOne Liquid CDx, a Comprehensive Pan-Tumor Liquid Biopsy Test

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Foundation Medicine, Inc. today announced that the U.S. Food and Drug Administration (FDA) approved FoundationOne®Liquid CDx, the Company’s comprehensive pan-tumor liquid biopsy test. FoundationOne Liquid CDx will be commercially available on Friday, August 28 and is covered across all solid tumors for eligible Medicare and Medicare Advantage beneficiaries in …

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Natera Partners with Massachusetts General Hospital for a Prospective Randomized Clinical Trial in Early Stage Breast Cancer

SAN CARLOS, Calif., Aug. 27, 2020 /PRNewswire/ — Natera, Inc. (NASDAQ: NTRA), a pioneer and global leader in cell-free DNA, today announced a collaborative agreement with Mass General Cancer Center (MGCC) of Massachusetts General Hospital, related to an investigator-initiated multi-center, Phase II randomized clinical trial of Ribociclib (Kisqali®), a CDK4/6 inhibitor, for the …

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Novartis Investigational Novel STAMP Inhibitor Asciminib Meets Primary Endpoint of Phase 3 Chronic Myeloid Leukemia Study

Basel, August 26, 2020 — Novartis announced today that, at primary analysis, the Phase III ASCEMBL study met its primary endpoint of statistically significant superiority in major molecular response (MMR) rate at 24 weeks for asciminib (ABL001) vs. bosutinib1. The study evaluates asciminib – a novel investigational treatment specifically targeting the …

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