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Oncology

Hematogenix Launches FDA Approved Companion Diagnostic Immuno-oncology Test for Triple-Negative Breast Cancer

TINLEY PARK, Ill., March 12, 2019 /PRNewswire/ — Hematogenix®- a global leader in the field of integrated pathology services for drug development and immuno-oncology testing, today announced the launch of the companion diagnostic test for the drug TECENTRIQ®. On March 8, 2019, the U.S. Food and Drug Administration (FDA) approved …

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Biocartis and Bristol-Myers Squibb Sign Collaboration Agreement for MSI Testing with Immuno-Oncology Therapies

Mechelen, Belgium, 12 March 2019 – Biocartis Group NV (the ‘Company’ or ‘Biocartis’), an innovative molecular diagnostics company (Euronext Brussels: BCART), today announced the signing of a collaboration agreement with Bristol-Myers Squibb Company (NYSE: BMY), a global biopharmaceutical company, aimed at the potential registration as a companion diagnostic and use of …

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FDA Approves Pfizer’s Trazimera, a Biosimilar to Herceptin

NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE: PFE) today announced the United States (U.S.) Food and Drug Administration (FDA) has approved TRAZIMERA™ (trastuzumab-qyyp), a biosimilar to Herceptin® (trastuzumab),1 for the treatment of human epidermal growth factor receptor-2 (HER2) overexpressing breast cancer and HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.2 “This is an important …

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Lilly’s Phase 3 Trial of Cyramza Met its Primary Endpoint, Significantly Improving PFS in First-Line Treatment in Metastatic EGFR-Mutated NSCLC

INDIANAPOLIS, March 12, 2019 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) today announced that its Phase 3 RELAY study of CYRAMZA® (ramucirumab) met its primary endpoint of progression-free survival (PFS), demonstrating a statistically significant improvement in the time patients lived without their cancer growing or spreading after starting treatment. The Phase 3 global, randomized, …

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FDA Grants Genentech’s Tecentriq in Combination With Abraxane Accelerated Approval for PD-L1-Positive, Metastatic TNBC

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced the U.S. Food and Drug Administration (FDA) has granted accelerated approval to Tecentriq®(atezolizumab) plus chemotherapy (Abraxane® [paclitaxel protein-bound particles for injectable suspension (albumin-bound); nab-paclitaxel]) for the treatment of adults with unresectable locally advanced or …

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Breast Cancer Patients Weigh In On Addressing Financial Burdens

A qualitative study led by researchers at the Johns Hopkins Bloomberg School of Public Health yielded nine patient-driven recommendations across circumstances that include changes to insurance, supportive services and financial assistance to reduce long-term, breast cancer-related economic burden. The study appears online March 6 in the journal Cancer. U.S. breast cancer patients …

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Eisai to Present Real World Evidence on Use of Halaven Injection Following CDK 4/6 Inhibitor

WOODCLIFF LAKE, N.J., March 6, 2019 /PRNewswire/ — Eisai announced today that new data from a real world observational study of the use of eribulin mesylate injection (marketed as HALAVEN®) following cyclin-dependent kinase (CDK) 4/6 inhibitor in community oncology practices will be presented during the 36th Miami Breast Cancer Conference …

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Celgene’s Fedratinib Granted Priority Review by the FDA for Treatment of Myelofibrosis

SUMMIT, N.J.–(BUSINESS WIRE)–Celgene Corporation (NASDAQ:CELG) today announced the U.S. Food and Drug Administration (FDA) has accepted the company’s New Drug Application (NDA) for fedratinib and granted a Priority Review. Fedratinib is a highly selective JAK2 inhibitor intended for the treatment of patients with myelofibrosis, a serious bone marrow disorder that …

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NantKwest Signs Worldwide License Agreement with ProMab to Develop Select Next Generation Targeted Natural Killer Cell Therapies

SAN DIEGO–(BUSINESS WIRE)–NantKwest, Inc. (Nasdaq:NK), a leading clinical-stage Natural Killer (NK) cell based therapeutics company, and ProMab Biotechnologies today announced the establishment of a worldwide license to a B-Cell Maturation Antigen (BCMA) targeted antibody sequence for multiple myeloma along with an option for up to five undisclosed targeting sequences for exclusive …

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ImmunoGen’s Ovarian Cancer Candidate Fails to Meet its Primary Endpoint in its Phase 3 Trial

WALTHAM, Mass.–(BUSINESS WIRE)–ImmunoGen, Inc., (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today announced that its Phase 3 FORWARD I trial evaluating the safety and efficacy of mirvetuximab soravtansine compared to chemotherapy in patients with folate receptor alpha (FRα)-positive, platinum-resistant ovarian …

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